Ems-2C
Ems-2C is a facial muscle cosmesis electrical stimulator (FDA Class II; FDA product code IPF, Stimulator, Muscle, Powered) made by Med Labs, Inc., cleared under FDA 510(k) K960457 on 6 Sep 1996 and listed in FDA GUDID since 12 Jul 2023 (UDI-DI G395EMS2C1), active as of 21 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 | NumberG395EMS2C1 | Date12 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK960457 | Date6 Sep 1996 | StatusActive |
Official records
- FDA 510(k) database K960457
Across registries
- FDA 510(k) K960457 decided 6 Sep 1996 Active
- FDA GUDID UDI-DI G395EMS2C1 listed 12 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K960457
- Listed FDA GUDID G395EMS2C1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Facial muscle cosmesis electrical stimulator
- Model / reference
- EMS-2C
- Description
- Electronic Muscle Stimulator Interrupted DC and Pulsed
- Primary DI / UDI-DI
- G395EMS2C1
- 510(k) Number
- FDA product code
- IPF
- GMDN term
- Facial muscle cosmesis electrical stimulator
- Device class
- Class II
- Regulation number
- 890.5850
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).
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- EMPI CONTINUUM by Empi
- SANYO ELECTRONIC MUSCLE STIMULATORS by GENERAL PHYSIOTHERAPY INC
- AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL by Biometer Intl. A/S
- EMS/400 by Altoona Medical Supply
- geko T-2 and geko T-3 Neuromuscular Stimulators by Firstkind Limited
- NEUROGAR IV-EXTERNAL NEURO-MUSCLE STIM. by Inter Med Industries, Inc.
- LINDQUIST MODEL 370 by R.J. Lindquist Co.