Feedback Box M025500D
by Intelligent Hearing Systems Corp.
Feedback Box M025500D is a Class II device made by Intelligent Hearing Systems Corp., cleared under FDA 510(k) K163326 on 29 Sep 2017 and listed in FDA GUDID since 10 Nov 2017 (UDI-DI 00817020020426), 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 | Number00817020020426 | Date10 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163326 | Date29 Sep 2017 | StatusActive |
Official records
- AccessGUDID record 00817020020426
- FDA 510(k) database K163326
Across registries
- FDA 510(k) K163326 decided 29 Sep 2017 Active
- FDA GUDID UDI-DI 00817020020426 listed 10 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K163326
- Listed FDA GUDID 00817020020426
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Feedback Box
- Generic name
- Biofeedback system
- Model / reference
- M025500D
- Primary DI / UDI-DI
- 00817020020426
- 510(k) Number
- FDA product code
- GWJ
- GMDN term
- Biofeedback system
- Device class
- Class II
- Regulation number
- 882.1900
- GUDID distribution status
- In Commercial Distribution
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