Submission Details
| 510(k) Number | K933194 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 1993 |
| Decision Date | July 13, 1994 |
| Days to Decision | 377 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
K933194 is an FDA 510(k) clearance for the THE SIGNATURE SERIES, IMC IV, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Progressive Electrical Therapeutics (Nevada, US). The FDA issued a Cleared decision on July 13, 1994, 377 days after receiving the submission on July 1, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K933194 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 1993 |
| Decision Date | July 13, 1994 |
| Days to Decision | 377 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5850 |