510(k) K944543 ยท GXY Electrode, Cutaneous
BIOFLEX GARMENTS, ASSORTED MODELS
| Applicant | Bioflex, Inc., Columbus OH, US |
| Decision | Substantially Equivalent, Jul 19, 1995 |
| Received | Sep 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944543
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2011 | Axiobionics, LLC AxioBionics Wearable Therapy Upper Extremity BioSleeve (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"x Terminated |
GXY | None listed |
| Aug 1, 2011 | Axiobionics, LLC 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" Terminated |
GXY | None listed |
| Aug 1, 2011 | Axiobionics, LLC 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".
Cutane Terminated |
GXY | None listed |
| Aug 1, 2011 | Axiobionics, LLC 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".
Terminated |
GXY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.