K852077 is an FDA 510(k) clearance for the VERSA STIM 380, MUSCLE STIMULATOR. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Electro-Med Health Industries, Inc. (Miami, US). The FDA issued a Cleared decision on August 21, 1985, 100 days after receiving the submission on May 13, 1985.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K852077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | May 13, 1985 |
| Decision Date | August 21, 1985 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |