Model 5400

Physical Medicine Devices

1

No

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, KS, MA, MI, MO, MS, NC, NM, NY, OK, PA, SC, SD, TN, TX, VA, WI, and the country of Canada.

Premier LifeCare Recliner 5400. Brochure is labeled in part: "***Premier LifeCare Recliner 5400***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Fully upholstered***Multiple side-table Options***3-position lockbar*** "No pinch" safety zone***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA.***" || Press on type label: "***Manufactured By Winco Ocala, FL 34474***Model No. 540***Serial No. 540-...***" || Press on type label: "***Model No. 557-...***Serial No.***". || Long-term multi-positional recliner.

Model 5570

Physical Medicine Devices

1

No

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, KS, MA, MI, MO, MS, NC, NM, NY, OK, PA, SC, SD, TN, TX, VA, WI, and the country of Canada.

Premier Care Recliner Model 5570. || Brochure: "***Premier Care Recliner 5570/5574***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Multiple side-table options***3-position lock-bar*** Fully upholstered***OPTIONAL Heat or Heat & Massage***OPTIONAL LiquiCell***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA.***" || Press on type label: "***Manufactured By Winco Ocala, FL 34474***Model No. 557***Serial No. 557-...***" || Press on type label: "***Model No. 557***Serial No.557-...***". || Long-term multi-positional recliner.

Baby Quasar- Model BQ-101, UPC Code 6 89076290272, Batch # 11253, 11523, 11658, 2382, 13009, 13177, 13186, 13243, 13270, 13306, 13327, 13342, 13459, 13528, 13529, 13635, 13730, 13767. Baby Quasar Pink- Model BQ-101-P, UPC 837654072172, Batch # 11927, 11945, 11989, 11990 12017,12073.

Physical Medicine Devices

2

No

Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, FL, GA, HI, ID, IL, KS, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OR, TN, TX, UT, VA, and WA; and countries of: Aruba, Canada, Cayman Islands, China, Estonia, Ireland, Malaysia, New Zealand, Singapore, Sweden, Taiwan, and United Kingdom.

Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) || are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest quality components and durable aluminum. Five Year Warranty || The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

Quasar MD- Model QMD-101 UPC Code 837654072196, Batch # 11652, 11727, 2441, 11870, 11884, 11955, 11969, 12005, 12006, 12029, 12057, 13008, 13193, 13199, 13221, 13242, 13271, 13288, 13325, 13514, 13521.

Physical Medicine Devices

2

No

Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, FL, GA, HI, ID, IL, KS, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OR, TN, TX, UT, VA, and WA; and countries of: Aruba, Canada, Cayman Islands, China, Estonia, Ireland, Malaysia, New Zealand, Singapore, Sweden, Taiwan, and United Kingdom.

Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" || The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

Quasar Power Pack- Model BPP-101 UPC Code 837654050170, Batch # 11253, 11523, 11658, 2382, 13009, 13177, 13186, 13243, 13270, 13306, 13327, 13342, 13459, 13528, 13529, 13635, 13730, 13767.

Physical Medicine Devices

2

No

Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, FL, GA, HI, ID, IL, KS, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OR, TN, TX, UT, VA, and WA; and countries of: Aruba, Canada, Cayman Islands, China, Estonia, Ireland, Malaysia, New Zealand, Singapore, Sweden, Taiwan, and United Kingdom.

Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. || The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWERPACK***FOR YOUTHFUL, RADIANT, CLEAR SKIN***SKIN REJUVENATING SYSTEM WITH SEQUEPULSE PLUS ADVANCED ACNE CLARIFYING SYSTEM***Manufactured by: Quasar Biotech, Inc., BPP101 LAB-003-E, ***Made in the USA with highest quality components and durable aluminum. Five Year Warranty.***"

Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973

Physical Medicine Devices

2

No

Nationwide Distribution including OH, NC, and NY.

BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: || Product Number: 2001249 BiOM Battery || Product Number: 2001240 BiOM Charger

Model #3G, Serial numbers: 12GE003750, 12GE003554 and 12HE001766.

Physical Medicine Devices

1

No

US Nationwide Distribution including the states of CA & MT.

Solara 3G Custom Manual Wheelchair || Product Usage: To provide mobility to a person restricted to a sitting position.

Item Number: A-642100    All Serial Numbers.

Physical Medicine Devices

1

No

US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.

Fixed Offset Adapter, A-642100. || The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).

Lot Numbers: 31480713, 31480721, 31968743, 31971619, 31990844, 32005711, 32018491, 32037764, 32118020, 32710832, 32736223, 33053264, 33105221, 33141176, 33164204, 33164407, 33276273, 33329911

Physical Medicine Devices

2

No

Nationwide Distribution.

Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. || Physical Therapy.

Lot Numbers: 32871821, 32976471, 33105247

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Numbers: 32901145, 33063999, 3132641, 3217556, 33276468, 33369411, 33412431, 33415413

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Numbers: 32871775, 32980891, 33132755, 33141184, 33217572, 33329945

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Number: 32871812

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Numbers: 32901129, 32980912, 33015541, 33024746, 33105239

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Model #209500

Physical Medicine Devices

2

No

US Nationwide and Middle East

The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. || Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.

Symbionic Item Numbers:   SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913  Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322

Physical Medicine Devices

US Nationwide distribution.

The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. || Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use.

Model 5570. Serial numbers: 557A1100178 thru 557A100206.

Physical Medicine Devices

1

No

Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.

PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. || The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

Model(s) 5251, 5261, 525S, 526S: Serial Numbers: 525108626 thru 525108774, 526100851 thru 526100919, 525S100070 thru 525S100081, 526S100037.

Physical Medicine Devices

1

No

Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.

CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. || The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

Model(s) 5271, 5281. Serial numbers: 527A101756 thru 527A101816, 528A100187 thru 528A100199.

Physical Medicine Devices

1

No

Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.

DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. || The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

Model(s) 5291, 529S. Serial numbers: 529A003767, 529A003779, 529A003787, 529A003790, 529A003792 thru 529A003865, 529S100044 thru 529100050.

Physical Medicine Devices

1

No

Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.

XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. || The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

SKU 348709 404, SKU348709 605

Physical Medicine Devices

1

No

Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, LA, MD, MI, MO, MT, NE, NV,NH, NM, NY, NC, OH,OK, and PA.

Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. || This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.

The devices in US distribution were manufactured between 29 September 2014 and 19 September 2015. Material Serialnumber 1C66=L22-2-P/0 201516011 1C66=L23-1-P/0 201525027 1C66=L23-2-P/0 201516014 201516016 201525022 1C66=L24-1-P/0 201516006 201516019 201525007 1C66=L24-2-P/0 201516002 201525012 201525020 1C66=L25-1-P/0 201449025 201518040 1C66=L25-2-P/0 201448015 201448019 201449020 201449034 201507001 201507005 201523037 1C66=L25-3-P/0 201448018 201449039 201507007 201507008 201507017 201514033 201518007 201528008 1C66=L26-1-P/0 201507006 1C66=L26-2-P/0 201444038 201444039 201444043 201444046 201444048 201449038 201507009 201507015 201507019 201528021 201528025 1C66=L26-3-P/0 201444004 201444014 201444037 201444040 201444047 201444049 201449001 201449004 201504007 201504011 201504020 201518026 1C66=L26-3-P/0 201518027 201518029 201518030 201518031 201523011 201523018 201523028 201523035 201523043 201523045 201523048 201529003 201529009 201529010 201529014 201529027 201529028 1C66=L27-2-P/0 201448012 201448020 201449008 201449013 201449027 201449030 201523027 1C66=L27-3-P/0 201444003 201444007 201444024 201444031 201444032 201444035 201444036 201444044 201449017 201449019 201449024 201449032 201449033 201504016 201504018 201504019 201504021 201504028 201518001 201518010 201518011 201518022 201518041 201523020 201528001 201528004 201528013 201528019 201528023 201529005 201529008 201529013 1C66=L27-3-P/0 201529015 201529017 201538031 1C66=L28-2-P/0 201507026 1C66=L28-3-P/0 201448022 201448023 201448027 201449037 201507027 201507028 201507029 201507030 201529040 201538014 1C66=L29-2-P/0 201507021 1C66=L29-3-P/0 201448007 201448008 201514001 201518013 201518024 201528007 201528022 201529023 201529024 1C66=R22-1-P/0 201516013 1C66=R23-1-P/0 201508008 201508020 201525039 1C66=R23-2-P/0 201508009 201508012 1C66=R24-2-P/0 201508016 201525026 1C66=R25-1-P/0 201448001 201507024 201507025 201518042 201523047 201528010 201528014 201529018 201529033 1C66=R25-2-P/0 201448006 201448009 201504004 201507032 201518016 201518043 1C66=R25-3-P/0 201448003 201448004 201448005 201504003 201504015 201504024 201514011 201514038 201518021 1C66=R25-3-P/0 201518036 201518049 201523013 201523032 201523034 1C66=R26-1-P/0 201448002 201504006 1C66=R26-2-P/0 201444002 201444008 201444025 201444028 201504009 201504013 201504026 201504027 201507016 201507023 201523024 1C66=R26-3-P/0 201448042 201448043 201448045 201448050 201504012 201504017 201504022 201504023 201504030 201507013 201507014 201507020 201518002 201518018 201518047 201523004 201523010 201523014 201523016 201523025 201523030 201523049 201523050 201529031 201529039 201538024 201538033 201538034 1C66=R27-2-P/0 201448033 201448035 201448036 201448040 201449023 201504014 201518014 201518032 201518045 201518050 1C66=R27-2-P/0 201523031 201529034 1C66=R27-3-P/0 201444010 201444015 201444016 201444017 201444023 201444027 201444029 201444034 201449005 201449009 201449021 201449026 201449031 201449035 201449040 201518017 201518023 201523003 201523005 201523006 201523017 201523026 201523033 201529019 201529045 1C66=R28-2-P/0 201507033 201510019 201518033 201523040 201529032 1C66=R28-3-P/0 201448029 201448034 201448039 201449002 201449010 201449014 201449022 201449036 201518009 201518039 201529020 1C66=R29-2-P/0 201507018 1C66=R29-3-P/0 201448041 201507010 201514002 201514020 201518037 201523038 201528009 201529002 201529026

Physical Medicine Devices

1

No

Worldwide Distribution - US (nationwide) and to the countries of : Austria, Belgium, Germany, Israel, Luxembourg and Sweden.

iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.

Model F00055-055 Standard Thermophore Lot codes:  0552712, 0552812, 0552912, 0553012, 0553112, 0553212, 0553312, 0553412, 0553512 , 0553612, 0553712, 0553812, 0553912, 0554012, 0554112, 0554212, 0554312, 0554412, 0554512, 0554612, 0554712, 0554812, 0554912, 0555012, 0555112, 0555212, 0550112, 0550213, 0550313, 0550413, 0550513, 0550613, 0550713, 0550813, 0550913, 0551013, 0551113, 0551213, 0551313, 0551413, 0551513, 0551613, 0551713, 0551813, 0551913, 0552013, 0552113, 0552213, 0552313, 0552413, 0552513, 0552613, 0552713, 0552813, 0552913, 0553013, 0553113, 0553213, 0553313, 0553413, 0553513, 0553613, 0553713, 0553813, 0553913, 0554013, 0554113, 0554213, 0554313, 0554413, 0554513, 0554613, 0554713, 0554813, 0554913, 055013, 0555113, 0555213, 0550113, 0550214, 0550314, 0550414, 0550514, 0550614, 0550714, 0550814, 0550914, 0551014, 0551114   Model F00255-255 Standard Thermophore Plus Lot codes: 2552712, 2552812, 2552912, 2553012, 2553112, 2553212, 2553312, 2553412, 2553512, 2553612, 2553712, 2553812, 2553912, 2554012, 2554112, 2554212, 2554312, 2554412, 2554512, 2554612, 2554712, 2554812, 2554912, 2555012, 2555112, 2555212, 2550112, 2550213, 2550313, 2550413, 2550513, 2550613, 2550713, 2550813, 2550913, 2551013, 2551113, 2551213, 2551313, 2551413, 2551513, 2551613, 2551713, 2551813, 2551913, 2552013, 2552113, 2552213, 2552313, 2552413, 2552513, 2552613, 2552713, 2552813, 2552913, 2553013, 2553113, 2553213, 2553313, 2553413, 2553513, 2553613, 2553713, 2553813, 2553913, 2554013, 2554113, 2554213, 2554313, 2554413, 2554513, 2554613, 2554713, 2554813, 2554913, 2555013, 2555113, 2555213, 2550113, 2550214, 2550314, 2550414, 2550514, 2550614, 2550714, 2550814, 2550914, 2551014, 2551114  Model F80095-095 Standard CSA Thermophore Lot code: 0952712, 0952812, 0952912, 0953012, 0953112, 0953212, 0953312, 0953412, 0953512, 0953612, 0953712, 0953812, 0953912, 0954012, 0954112, 0954212, 0954312, 0954412, 0954512, 0954612, 0954712, 0954812, 0954912, 0955012, 0955112, 0955212, 0950112, 0950213, 0950313, 0950413, 0950513, 0950613, 0950713, 0950813, 0950913, 0951013, 0951113, 0951213, 0951313, 0951413, 0951513, 0951613, 0951713, 0951813, 0951913, 0952013, 0952113, 0952213, 0952313, 0952413, 0952513, 0952613, 0952713, 0952813, 0952913, 0953013, 0953113, 0953213, 0953313, 0953413, 0953513, 0953613, 0953713, 0953813, 0953913, 0954013, 0954113, 0954213, 0954313, 0954413, 0954513, 0954613, 0954713, 0954813, 0954913, 0955013, 0955113, 0955213, 0950113, 0950214, 0950314, 0950414, 0950514, 0950614, 0950714, 0950814, 0950914, 0951014, 0951114    Model F00077-077 Petite Thermophore Lot codes:  0772712, 0772812, 0772912, 0773012, 0773112, 0773212, 0773312, 0773412, 0773512, 0773612, 0773712, 0773812, 0773912, 0774012, 0774112, 0774212, 0774312, 0774412, 0774512, 0774612, 0774712, 0774812, 0774912, 0775012, 0775112, 0775212, 0770112, 0770213, 0770313, 0770413, 0770513, 0770613, 0770713, 0770813, 0770913, 0771013, 0771113, 0771213, 0771313, 0771413, 0771513, 0771613, 0771713, 0771813, 0771913, 0772013, 0772113, 0772213, 0772313, 0772413, 0772513, 0772613, 0772713, 0772813, 0772913, 0773013, 0773113, 0773213, 0773313, 0773413, 0773513, 0773613, 0773713, 0773813, 0773913, 0774013, 0774113, 0774213, 0774313, 0774413, 0774513, 0774613, 0774713, 0774813, 0774913, 0775013, 0775113, 0775213, 0770113, 0770214, 0770314, 0770414, 0770514, 0770614, 0770714, 0770814, 0770914, 0771014, 0771114, 0771214, 0771314, 0771414, 0771514, 0771614, 0771714, 0771814, 0771914, 0772014, 0772114, 0772214, 0772314, 0772414, 0772514, 0772614, 0772714  Model F00277-277 Petite Thermophore Plus lot codes: 2772712, 2772812, 2772912, 2773012, 2773112, 2773212, 2773312, 2773412, 2773512, 2773612, 2773712, 2773812, 2773912, 2774012, 2774112, 2774212, 2774312, 2774412, 2774512, 2774612, 2774712, 2774812, 2774912, 2775012, 2775112, 2775212, 2770112, 2770213, 2770313, 2770413, 2770513, 2770613, 2770713, 2770813, 2770913, 2771013, 2771113, 2771213, 2771313, 2771413, 2771513, 2771613, 2771713, 2771813, 2771913, 2772013, 2772113, 2772213, 2772313, 2772413, 2772513, 2772613, 2772713, 2772813, 2772913, 2773013, 2773113, 2773213, 2773313, 2773413, 2773513, 2773613, 2773713, 2773813, 2773913, 2774013, 2774113, 2774213, 2774313, 2774413, 2774513, 2774613, 2774713, 2774813, 2774913, 2775013, 2775113, 2775213, 2770113, 2770214, 2770314, 2770414, 2770514, 2770614, 2770714, 2770814, 2770914, 2771014, 2771114, 2771214, 2771314, 2771414, 2771514, 2771614, 2771714, 2771814, 2771914, 2772014, 2772114, 2772214, 2772314, 2772414, 2772514, 2772614, 2772714   Model F80097-097 Petite CSA Thermophore Lot codes: 0972712, 0972812, 0972912, 0973012, 0973112, 0973212, 0973312, 0973412, 0973512, 0973612, 0973712, 0973812, 0973912, 0974012, 0974112, 0974212, 0974312, 0974412, 0974512, 0974612, 0974712, 0974812, 0974912, 0975012, 0975112, 0975212, 0970112, 0970213, 0970313, 0970413, 0970513, 0970613, 0970713, 0970813, 0970913, 0971013, 0971113, 0971213, 0971313, 0971413, 0971513, 0971613, 0971713, 0971813, 0971913, 0972013, 0972113, 0972213, 0972313, 0972413, 0972513, 0972613, 0972713, 0972813, 0972913, 0973013, 0973113, 0973213, 0973313, 0973413, 0973513, 0973613, 0973713, 0973813, 0973913, 0974013, 0974113, 0974213, 0974313, 0974413, 0974513, 0974613, 0974713, 0974813, 0974913, 0975013, 0975113, 0975213, 0970113, 0970214, 0970314, 0970414, 0970514, 0970614, 0970714, 0970814, 0970914, 0971014, 0971114, 0971214, 0971314, 0971414, 0971514, 0971614, 0971714, 0971814, 0971914, 0972014, 0972114, 0972214, 0972314, 0972414, 0972514, 0972614, 0972714   Model F00056-056 Medium Thermophore Lot codes: 0562712, 0562812, 0562912, 0563012, 0563112, 0563212, 0563312, 0563412, 0563512, 0563612, 0563712, 0563812, 0563912, 0564012, 0564112, 0564212, 0564312, 0564412, 0564512, 0564612, 0564712, 0564812, 0564912, 0565012, 0565112, 0565212, 0560112, 0560213, 0560313, 0560413, 0560513, 0560613, 0560713, 0560813, 0560913, 0561013, 0561113, 0561213, 0561313, 0561413, 0561513, 0561613, 0561713, 0561813, 0561913, 0562013, 0562113, 0562213, 0562313, 0562413, 0562513, 0562613, 0562713, 0562813, 0562913, 0563013, 0563113, 0563213, 0563313, 0563413, 0563513, 0563613, 0563713, 0563813, 0563913, 0564013, 0564113, 0564213, 0564313, 0564413, 0564513, 0564613, 0564713, 0564813, 0564913, 0565013, 0565113, 0565213, 0560113, 0560214, 0560314, 0560414, 0560514, 0560614, 0560714, 0560814, 0560914, 0561014, 0561114, 0561214, 0561314, 0561414, 0561514, 0561614, 0561714, 0561814, 0561914,0562014, 0562114, 0562214, 0562314, 0562414, 0562514, 0562614, 0562714, 0562814, 0562914  Model-F00256-256 Medium thermophore Plus lot codes:  2562712, 2562812, 2562912, 2563012, 2563112, 2563212, 2563312, 2563412, 2563512, 2563612, 2563712, 2563812, 2563912, 2564012, 2564112, 2564212, 2564312, 2564412, 2564512, 2564612, 2564712, 2564812, 2564912, 2565012, 2565112, 2565212, 2560112, 2560213, 2560313, 2560413, 2560513, 2560613, 2560713, 2560813, 2560913, 2561013, 2561113, 2561213, 2561313, 2561413, 2561513, 2561613, 2561713, 2561813, 2561913, 2562013, 2562113, 2562213, 2562313, 2562413, 2562513, 2562613, 2562713, 2562813, 2562913, 2563013, 2563113, 2563213, 2563313, 2563413, 2563513, 2563613, 2563713, 2563813, 2563913, 2564013, 2564113, 2564213, 2564313, 2564413, 2564513, 2564613, 2564713, 2564813, 2564913, 2565013, 2565113, 2565213, 2560113, 2560214, 2560314, 2560414, 2560514, 2560614, 2560714, 2560814, 2560914, 2561014, 2561114, 2561214, 2561314, 2561414, 2561514, 2561614, 2561714, 2561814, 2561914, 2562014, 2562114, 2562214, 2562314, 2562414, 2562514, 2562614, 2562714, 2562814, 2562914  Model F80096-096 Medium CSA Thermophore Lot codes:  0962712, 0962812, 0962912, 0963012, 0963112, 0963212, 0963312, 0963412, 0963512, 0963612, 0963712, 0963812, 0963912, 0964012, 0964112, 0964212, 0964312, 0964412, 0964512, 0964612, 0964712, 0964812, 0964912, 0965012, 0965112, 0965212, 0960112, 0960213, 0960313, 0960413, 0960513, 0960613, 0960713, 0960813, 0960913, 0961013, 0961113, 0961213, 0961313, 0961413, 0961513, 0961613, 0961713, 0961813, 0961913, 0962013, 0962113, 0962213, 0962313, 0962413, 0962513, 0962613, 0962713, 0962813, 0962913, 0963013, 0963113, 0963213, 0963313, 0963413, 0963513, 0963613, 0963713, 0963813, 0963913, 0964013, 0964113, 0964213, 0964313, 0964413, 0964513, 0964613, 0964713, 0964813, 0964913, 0965013, 0965113, 0965213, 0960113, 0960214, 0960314, 0960414, 0960514, 0960614, 0960714, 0960814, 0960914, 0961014, 096111, 40961214, 0961314, 0961414, 0961514, 0961614, 0961714, 0961814, 0961914, 0962014, 0962114, 0962214, 0962314, 0962414, 0962514, 0962614, 0962714, 0962814, 0962914

Physical Medicine Devices

2

No

Distributed within the United States, Canada, Mexico, Puerto Rico and Columbia

Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", || Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", || Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 || Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" || Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", || Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", || Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 || Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" || Used for the temporary relief of joint and muscle pain.

Item# Lot Number(s)  SL2103 1605BC02A, 1606BC02A  V'-SL2104 1605BC03A, 1606BC03A, 1607BC03A  V'-SL2105 1605BC04A, 1606BC04A, 1607BC04A  V'-SL2106 1605BC05A, 1606BC05A, 1607BC05A ASL2150 1605BC06A, 1607BC06A

Physical Medicine Devices

1

No

US Nationwide Distribution.

Medi Choice Arm Slings || ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA || ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA || ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA || ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA || ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA || Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

Part No. 32291, Kit 33372, Kit UDI - Primary ID: 09008737333720 (anthracite 50); Part No. 32292, Kit 33374, Kit UDI - Primary ID: 09008737333744 (ebony 50); Part No. 32293, Kit 33375, Kit UDI - Primary ID: 09008737333751 (black 50); Part No. 32294, Kit 33376, Kit UDI - Primary ID: 09008737333768 (white 50); Part No. 32295, Kit 33377, Kit UDI - Primary ID: 09008737333775 (beige 50) and Part No. 32296, Kit 33378, Kit UDI - Primary ID: 09008737333782 (grey 50).

Physical Medicine Devices

1

No

Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.

SONNET Mini Battery Pack CableProduct Usage: || The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.