WEARABLE THERAPY GARMENTS
AXIOBIONICS LLC
AXIOBIONICS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008525454 | 3008525454 | Axiobionics, LLC, Center for Neuroprosthetics | 1 | N | 2026-01-01 | 6111 Jackson Road Suite 200 Ann Arbor MI US 48103 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 120123 | 1967655015 | K951951 | FOCUS MODEL 795 UNIT | GZJ | 1996-05-17 |
| 120123 | 1157438770 | K944543 | BIOFLEX GARMENTS, ASSORTED MODELS | GXY | 1995-07-19 |
| 120123 | 2046860830 | K900029 | SPECTRASTIM 2000 MUSCLE STIMULATOR | IPF | 1990-04-02 |
| 120123 | 1241742616 | K141342 | WEARABLE THERAPY GARMENTS | GXY | 2014-11-14 |
| 120123 | 1801697481 | K093324 | EMPI CONTINUUM | IPF | 2010-03-05 |
| 120123 | 1954671628 | K071951 | COMFY SERIES: EV-804, EV-805 & EV-806 | GZJ | 2007-09-05 |
| 120123 | 1248140907 | K021100 | 300 PV COMPLETE ELECTROTHERAPY SYSTEM | IPF | 2002-06-18 |
| 120123 | 1797033788 |
Product Codes Associated With Registrations#
PMN#
GUDID#
EMPI Focus 2 Channel Stimulator - Neuromuscular Stimulator
2016-09-24
Axio 2 Channel Stimulator - Neuromuscular Stimulator
2016-09-24
Axio 4 Channel Stimulator - Neuromuscular Stimulator
2016-09-24
EMPI 300PV Stimulator - Neuromuscular Stimulator
2016-09-24
EMPI Continuum - Neuromuscular Stimulator
2016-09-24
OOFS Pace XL Stimulator - Neuromuscular Stimulator
2018-12-27
UE BioSleeve - Cutaneous Electrode GarmentReleased as revision 5 on 2017-11-28
2021-01-08
BioCollar - Cutaneous Electrode Garment
2016-09-24
BioCollar - Cutaneous Electrode Garment
2017-02-20
BioMiniVest - Cutaneous Electrode Garment
2016-09-24
BioVest - Cutaneous Electrode Garment
2016-09-24
BioUnitard - Cutaneous Electrode Garment
2016-09-24
BioMiniBelt - Cutaneous Electrode Garment
2016-09-24
BioBelt Lumbar - Cutaneous Electrode Garment
2016-09-24
BioBelt Lumbar Contoured - Cutaneous Electrode Garment
2016-09-24
BioBelt Ab - Cutaneous Electrode Garment
2016-09-24
BioBelt Ab Large Expanded - Cutaneous Electrode Garment
2017-05-22
Adhesive Electrode - Adhesive Cutaneous Electrode Monthly Supply 2” x 3.5”
2016-09-24
BioGel Velcro Electrode - Cutaneous Electrode Pair 1.25” x 1.25”
2016-09-24
BioGel Velcro Electrode - Cutaneous Electrode Pair 1.5” x 1.5”
2016-09-24
BioGel Velcro Electrode - Cutaneous Electrode Pair 1.5” x 2”
2016-09-24
BioGel Velcro Electrode - Cutaneous Electrode Pair 2” x 2”
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 2"" x 2.5"""
2016-09-24
BioGel Velcro Electrode - Cutaneous Electrode Pair 2” x 3”
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 2"" x 3.5"""
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 2"" x 4"""
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 2"" x 5"""
2016-09-24
BioGel Velcro Electrode - Cutaneous Electrode Pair 2” x 6”
2016-09-24
BioGel Velcro Electrode - Cutaneous Electrode Pair 2” x 8”
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 1.5"" x 3"""
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 1.5"" x 5"""
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 1.5"" x 6"""
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 1"" x 1.5"""
2016-09-24
BioGel Velcro Electrode - Cutaneous Electrode Pair 3” x 5”
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 3.5"" x 3.5"" "
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 4"" x 4"" "
2016-09-24
BioGel Velcro Electrode - "Cutaneous Electrode Pair 4"" x 6"""
2016-09-24
UE BioSleeve - Cutaneous Electrode Garment
2016-09-24
UE BioSleeve - Cutaneous Electrode Garment
2016-09-24
UE BioSleeve - Cutaneous Electrode Garment
2016-09-24