Devices

Device Recall AxioBionics Wearable Therapy BioShorts

Model / 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.
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 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
- Recall of Device Recall AxioBionics Wearable Therapy BioShorts

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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