PainKARE PK001
PainKARE PK001 is a medical device (FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter) made by Triowave Technologies, cleared under FDA 510(k) K151034 on 21 Nov 2015 and listed in FDA GUDID since 15 Nov 2017 (UDI-DI 00866946000302), 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 | Number00866946000302 | Date15 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151034 | Date21 Nov 2015 | StatusActive |
Official records
- AccessGUDID record 00866946000302
- FDA 510(k) database K151034
Across registries
- FDA 510(k) K151034 decided 21 Nov 2015 Active
- FDA GUDID UDI-DI 00866946000302 listed 15 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K151034
- Listed FDA GUDID 00866946000302
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PainKARE
- Generic name
- Analgesic transcutaneous electrical nerve stimulation system
- Model / reference
- PK001
- Primary DI / UDI-DI
- 00866946000302
- 510(k) Number
- FDA product code
- NUH
- GMDN term
- Analgesic transcutaneous electrical nerve stimulation system
- Device class
- Class II
- Regulation number
- 882.5890
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Analgesic transcutaneous electrical nerve stimulation system.