Sensiv SENTENSSP
by Acutens Inc
Sensiv SENTENSSP is a Class II device made by Acutens Inc, cleared under FDA 510(k) K171381 on 13 Dec 2017 and listed in FDA GUDID since 29 Nov 2022 (UDI-DI 00850033118131), 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 | Number00850033118131 | Date29 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171381 | Date13 Dec 2017 | StatusActive |
Official records
- AccessGUDID record 00850033118131
- FDA 510(k) database K171381
Across registries
- FDA 510(k) K171381 decided 13 Dec 2017 Active
- FDA GUDID UDI-DI 00850033118131 listed 29 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K171381
- Listed FDA GUDID 00850033118131
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sensiv
- Generic name
- Transcutaneous electrical stimulation electrode, single-use
- Model / reference
- SENTENSSP
- Primary DI / UDI-DI
- 00850033118131
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Transcutaneous electrical stimulation electrode, single-use
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
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