Focus Model 795 Unit
by Empi
510(k) K951951
Focus Model 795 Unit is a Class II device made by Empi, cleared under FDA 510(k) K951951 on 17 May 1996, 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 | NumberK951951 | Date17 May 1996 | StatusActive |
Official records
- FDA 510(k) database K951951
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- Withdrawn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 K951951
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 | |||
|---|---|---|---|---|
| EMPI Focus 2 Channel Stimulator 0 | 11001 / 0 | B36711001L00 | — | On the market |
Similar devices
Other devices filed under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief).
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- AUTO-TENS MODEL II SINGLE CHANNEL by Cbc Corp.
- STIMULATOR, ELECTRICAL NERVE by Electreat, Inc.
- XCEL MODEL XE-1 by Electrocaine Medical System
- Z TECH TRANSCUTANEOUS NEURAL STIMULATION by Z Technologies, LLC
- TENSWave by Zynex Medical Officer
- TX-3(TENS) by Oms Medico, Inc.