MyndMove 2.0 MyndMove FES System
MyndMove 2.0 MyndMove FES System (920200) is a Class II device made by Myndtec, Inc., cleared under FDA 510(k) K212149 on 3 Mar 2022 and listed in FDA GUDID since 19 Aug 2022 (UDI-DI 00692520202004), active as of 22 Oct 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 | Number00692520202004 | Date19 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212149 | Date3 Mar 2022 | StatusActive |
Official records
- AccessGUDID record 00692520202004
- FDA 510(k) database K212149
Across registries
- FDA 510(k) K212149 decided 3 Mar 2022 Active
- FDA GUDID UDI-DI 00692520202004 listed 19 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K212149
- Listed FDA GUDID 00692520202004
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MyndMove 2.0
- Generic name
- Neuromuscular transmission electrode
- Model / Ref / Catalog
- MyndMove FES System, 920200
- Primary DI / UDI-DI
- 00692520202004
- 510(k) Number
- FDA product code
- IPF, GZI
- GMDN term
- Neuromuscular transmission electrode
- Device class
- Class II
- Regulation number
- 890.5850, 882.5810
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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