Sensus Se-SK4
Sensus Se-SK4, a medical device (FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter) made by Neurometrix, Inc., was cleared under FDA 510(k) K130919 on 2 Jul 2013 and listed in FDA GUDID on 9 Sep 2016 (UDI-DI 00851221006322); the registry lists it as not in commercial distribution (GUDID) 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 | Number00851221006322 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130919 | Date2 Jul 2013 | StatusActive |
Official records
- AccessGUDID record 00851221006322
- FDA 510(k) database K130919
Across registries
- FDA 510(k) K130919 decided 2 Jul 2013 Active
- FDA GUDID UDI-DI 00851221006322 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K130919
- Listed FDA GUDID 00851221006322
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sensus
- Generic name
- Analgesic transcutaneous electrical nerve stimulation system
- Model / reference
- SE-SK4
- Description
- SENSUS System Kit, 2 Devices (Includes 2 SE-S01) 2 SE-001 and 2 SE-S01 or QE-P01
- Primary DI / UDI-DI
- 00851221006322
- FDA product code
- NUH
- GMDN term
- Analgesic transcutaneous electrical nerve stimulation system
- Device class
- Class II
- Regulation number
- 882.5890
- GUDID distribution status
- Not in Commercial Distribution
Similar devices in this category
Other devices filed under Analgesic transcutaneous electrical nerve stimulation system.