Devices

Device Recall AxioBionics Wearable Therapy FreeStep Sleeve

Model / 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.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution--USA (nationwide) including the states of AZ, GA, IL, IN, MI, MO, NY, TX, and WY.
Product Description
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
- Recall of Device Recall AxioBionics Wearable Therapy FreeStep Sleeve

Manufacturer

Axiobionics, LLC

Manufacturer Address
Axiobionics, LLC, 6111 Jackson Rd, Ann Arbor MI 48103-9167
Manufacturer Parent Company (2017)
Axiobionics
Source
USFDA

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