MyOnyx SA9000
MyOnyx SA9000 is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K053434 on 15 Mar 2006 and listed in FDA GUDID since 16 Jul 2020 (UDI-DI 07540191000555), 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 | Number07540191000555 | Date16 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK053434 | Date15 Mar 2006 | StatusActive |
Official records
- AccessGUDID record 07540191000555
- FDA 510(k) database K053434
Across registries
- FDA 510(k) K053434 decided 15 Mar 2006 Active
- FDA GUDID UDI-DI 07540191000555 listed 16 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K053434
- Listed FDA GUDID 07540191000555
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MyOnyx
- Generic name
- Psychophysiological biofeedback system
- Model / reference
- SA9000
- Primary DI / UDI-DI
- 07540191000555
- 510(k) Number
- FDA product code
- HCC, KPI, IPF
- GMDN term
- Psychophysiological biofeedback system
- Device class
- Class II
- Regulation number
- 882.5050, 876.5320, 890.5850
- GUDID distribution status
- In Commercial Distribution
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- RELAXOMAT by Relaxomat, Inc.
- EEG BIOFEEDBACK DEVICE by Electronics Research & Production
- ALPHAONE BIOFEEDBACK SYSTEM by Telediagnostic Systems, Inc.
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- GRINDCARE by Medotech A/S