The following data is part of a premarket notification filed by Med Labs, Inc. with the FDA for Electronic Muscle Stimulator Model Ems-1c/ems-2c.
| Device ID | K960457 |
| 510k Number | K960457 |
| Device Name: | ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C |
| Classification | Stimulator, Muscle, Powered |
| Applicant | MED LABS, INC. 28 VEREDA CORDILLERA Goleta, CA 93117 |
| Contact | Gloria Norvell |
| Correspondent | Gloria Norvell MED LABS, INC. 28 VEREDA CORDILLERA Goleta, CA 93117 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-30 |
| Decision Date | 1996-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G395EMS2C1 | K960457 | 000 |
| G395EMS1C1 | K960457 | 000 |