K960457 is an FDA 510(k) clearance for the ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Med Labs, Inc. (Goleta, US). The FDA issued a Cleared decision on September 6, 1996, 220 days after receiving the submission on January 30, 1996.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K960457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1996 |
| Decision Date | September 06, 1996 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |