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Preguntas frecuentes
Créditos
Devices
Device Recall AxioBionics Wearable Therapy BioShorts
Modelo / Serial
Catalog numbers for the BioShorts include 10210 with Serial numbers 1470, 1370, 1421, 1388, 1451, 1401, 1501, 1408 and 1538. Catalog numbers for the BioGel Velcro Electrodes include118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, and 130.
Clasificación del producto
Neurological Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
Nationwide Distribution--USA (nationwide) including the states of AZ, GA, IL, IN, MI, MO, NY, TX, and WY.
Descripción del producto
AxioBionics Wearable Therapy BioShorts that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". || Cutaneous electrode garments for neuromuscular electrical stimulation.
Manufacturer
Axiobionics, LLC
1 Event
Retiro De Equipo (Recall) de Device Recall AxioBionics Wearable Therapy BioShorts
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Fabricante
Axiobionics, LLC
Dirección del fabricante
Axiobionics, LLC, 6111 Jackson Rd, Ann Arbor MI 48103-9167
Empresa matriz del fabricante (2017)
Axiobionics
Source
USFDA
Language
English
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