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Device Recall AxioBionics Wearable Therapy BioVest/Unitard
Model / Serial
Catalog numbers for the BioVest/Unitard: 1024 with Serial numbers 1375, 1400, 1411, 1424, 1465, 1499 and 1527. 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 BioVest/Unitard 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 BioVest/Unitard
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Manufacturer
Axiobionics, LLC
Manufacturer Address
Axiobionics, LLC, 6111 Jackson Rd, Ann Arbor MI 48103-9167
Manufacturer Parent Company (2017)
Axiobionics
Source
USFDA
Language
English
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