Tens/If 14
by Emsi
510(k) K071869
Tens/If 14 is a Class II device made by Emsi, cleared under FDA 510(k) K071869 on 7 Mar 2008, 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 | FDA 510(k)SESE | NumberK071869 | Date7 Mar 2008 | StatusActive |
Official records
- FDA 510(k) database K071869
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GZJ
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K071869
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Flex-IT Retail 022017 FLEI0001R02 | FLEI0001R02 | 00858688006940 | No longer on the market | |
| Flex-IT Retail FLEI0001R | FLEI0001R | 00858688006070 | On the market | |
| Flex-TENS FLET0001 | FLET0001 | 00858688006001 | On the market | |
| Flex-TENS Retail 022017 FLET0001R02 | FLET0001R02 | 00858688006957 | No longer on the market | |
| Flex-TENS Retail FLET0001R | FLET0001R | 00858688006087 | On the market |
Similar devices
Other devices filed under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief).
- POINTER F-3 TENS by Oms Medical Supplies, Inc.
- NURITE II by Bio-Medical Systems Corp.
- MED-4000 by Micro Current Technology, Inc.
- TENS device-EmeTerm, CinvStop by Wat Medical Technology (Ningbo) Co., Ltd.
- NEURON II AND MICROTENS by Datran Corp.
- ACCU-O-MATIC by Myomed, Inc.
- EZ GRIP REUSABLE TENS/NMES ELECTRODES by Advanced Adhesives
- 'TENSAID' by Electro Therapeutic Devices, Inc.
- MEDS-4 NEUROMUSCULAR STIMULATOR by Medical Equipment Device Specialists
- iRelieve Microcurrent Pain Relief System by Fast Track Technologies, Inc.