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Créditos
Devices
Device Recall AxioBionics Wearable Therapy FreeStep Sleeve
Modelo / Serial
Catalog numbers for the FreeStep Sleeves include 10000 and 10001 with Serial numbers 1436 and 1458. 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 TherapyFreeStep Sleeve (Right and Left) 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 FreeStep Sleeve
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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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