Submission Details
| 510(k) Number | K901779 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 17, 1990 |
| Decision Date | June 26, 1990 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K901779 is an FDA 510(k) clearance for the RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on June 26, 1990, 70 days after receiving the submission on April 17, 1990. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K901779 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 17, 1990 |
| Decision Date | June 26, 1990 |
| Days to Decision | 70 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 |