Myotrac 3 Unit SA9900
Myotrac 3 Unit SA9900 is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K925681 on 29 Sep 1995 and listed in FDA GUDID since 29 Oct 2019 (UDI-DI 07540191000494), active as of 23 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 | Number07540191000494 | Date29 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK925681 | Date29 Sep 1995 | StatusActive |
Official records
- AccessGUDID record 07540191000494
- FDA 510(k) database K925681
Across registries
- FDA 510(k) K925681 decided 29 Sep 1995 Active
- FDA GUDID UDI-DI 07540191000494 listed 29 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K925681
- Listed FDA GUDID 07540191000494
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Myotrac 3 Unit
- Generic name
- Pelvic floor muscle exerciser
- Model / reference
- SA9900
- Primary DI / UDI-DI
- 07540191000494
- 510(k) Number
- FDA product code
- HIR
- GMDN term
- Pelvic floor muscle exerciser
- Device class
- Class II
- Regulation number
- 884.1425
- GUDID distribution status
- In Commercial Distribution
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