Flex-IT Retail FLEI0001R
by Emsi
Flex-IT Retail FLEI0001R 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 00858688006070), 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 | Number00858688006070 | Date2 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071869 | Date7 Mar 2008 | StatusActive |
Official records
- AccessGUDID record 00858688006070
- FDA 510(k) database K071869
Across registries
- FDA 510(k) K071869 decided 7 Mar 2008 Active
- FDA GUDID UDI-DI 00858688006070 listed 2 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K071869
- Listed FDA GUDID 00858688006070
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flex-IT Retail
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / reference
- FLEI0001R
- Primary DI / UDI-DI
- 00858688006070
- 510(k) Number
- FDA product code
- GZJ, LIH
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical 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 Physical therapy transcutaneous neuromuscular electrical stimulation system.