Flex-TENS FLET0001
by Emsi
Flex-TENS FLET0001 is a Class II device made by Emsi, cleared under FDA 510(k) K071869 on 7 Mar 2008 and listed in FDA GUDID since 2 Sep 2016 (UDI-DI 00858688006001), 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 | Number00858688006001 | Date2 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071869 | Date7 Mar 2008 | StatusActive |
Official records
- AccessGUDID record 00858688006001
- FDA 510(k) database K071869
Across registries
- FDA 510(k) K071869 decided 7 Mar 2008 Active
- FDA GUDID UDI-DI 00858688006001 listed 2 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K071869
- Listed FDA GUDID 00858688006001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flex-TENS
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / reference
- FLET0001
- Primary DI / UDI-DI
- 00858688006001
- 510(k) Number
- FDA product code
- LIH, GZJ
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 882.5890
- GUDID distribution status
- In Commercial Distribution
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