Focus
Focus is a Class II device made by Neurosoft, Ooo, cleared under FDA 510(k) K102610 on 4 Mar 2011 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 04650075330074), active as of 21 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 | Number04650075330074 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102610 | Date4 Mar 2011 | StatusActive |
Official records
- AccessGUDID record 04650075330074
- FDA 510(k) database K102610
Across registries
- FDA 510(k) K102610 decided 4 Mar 2011 Active
- FDA GUDID UDI-DI 04650075330074 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K102610
- Listed FDA GUDID 04650075330074
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electromyograph
- Model / reference
- Focus
- Primary DI / UDI-DI
- 04650075330074
- 510(k) Number
- FDA product code
- JXE, IKN
- GMDN term
- Electromyograph
- Device class
- Class II
- Regulation number
- 882.1550, 890.1375
- GUDID distribution status
- In Commercial Distribution
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