NeuroInfiniti SA7550
NeuroInfiniti SA7550 is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K903497 on 12 Feb 1991 and listed in FDA GUDID since 6 Jul 2026 (UDI-DI 07540191000678), 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 | Number07540191000678 | Date6 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK903497 | Date12 Feb 1991 | StatusActive |
Official records
- AccessGUDID record 07540191000678
- FDA 510(k) database K903497
Across registries
- FDA 510(k) K903497 decided 12 Feb 1991 Active
- FDA GUDID UDI-DI 07540191000678 listed 6 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K903497
- Listed FDA GUDID 07540191000678
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NeuroInfiniti
- Generic name
- Psychophysiological biofeedback system
- Model / reference
- SA7550
- Primary DI / UDI-DI
- 07540191000678
- 510(k) Number
- FDA product code
- HCC
- GMDN term
- Psychophysiological biofeedback system
- Device class
- Class II
- Regulation number
- 882.5050
- GUDID distribution status
- In Commercial Distribution
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