WalkAnalyst Software Kit 20-0603
WalkAnalyst Software Kit 20-0603 is a Class II device made by Innovative Neurotronics, cleared under FDA 510(k) K140886 on 8 Aug 2014 and listed in FDA GUDID since 16 Aug 2016 (UDI-DI 00858184006130), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00858184006130 | Date16 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140886 | Date8 Aug 2014 | StatusActive |
Official records
- AccessGUDID record 00858184006130
- FDA 510(k) database K140886
Across registries
- FDA 510(k) K140886 decided 8 Aug 2014 Active
- FDA GUDID UDI-DI 00858184006130 listed 16 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K140886
- Listed FDA GUDID 00858184006130
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- WalkAnalyst Software Kit
- Generic name
- Gait-enhancement electrical stimulation system, external
- Model / reference
- 20-0603
- Primary DI / UDI-DI
- 00858184006130
- 510(k) Number
- FDA product code
- GZI
- GMDN term
- Gait-enhancement electrical stimulation system, external
- Device class
- Class II
- Regulation number
- 882.5810
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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