K802107 is an FDA 510(k) clearance for the EGS #300 BATTERY OPER. PORTA. MUSCLE STI. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Electro-Med Health Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980, 30 days after receiving the submission on September 3, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K802107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1980 |
| Decision Date | October 03, 1980 |
| Days to Decision | 30 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 |