FDA Registration
Active
🇺🇸 United States
Axiobionics, LLC, Center for Neuroprosthetics
Reg #: 3008525454
·
FEI: 3008525454
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- Axiobionics, LLC, Center for Neuroprosthetics
- Registration Number
- 3008525454
- FEI Number
- 3008525454
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6111 Jackson Road, Suite 200
- City
- Ann Arbor
- State
- MI
- ZIP
- 48103
- Country
- US
Regulatory Submissions
- 510(k) Number
- K071951
Owner / Operator
- Firm Name
- Axiobionics, LLC
- Operator Number
- 9010991
- Address
- 6111 Jackson Road, Suite 200
- City
- Ann Arbor
- State
- MI
- Postal Code
- 48103
- Country
- US
- Correspondent
- Philip Muccio
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2016-09-23 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2016-09-23 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2020-09-15 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2010-08-13 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2016-09-23 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2016-09-23 |
Proprietary Names
Axio 2 channel NMES/TENS
Tripleflex Dynamic Orthosis
Axiobionics
Osteovest
Wearable Therapy
Free Step
NeuroPro 4
Continuum 2 channel NMES/TENS/FES
300 PV 2 channel NMES/TENS/FES/IF
Focus 2 channel NMES/TENS/FES
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Remanufacture Medical Device