K062354 is an FDA 510(k) clearance for the VECTRA GENISYS VMS FR. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Encore Medical, L.P. (Hixson, US). The FDA issued a Cleared decision on January 26, 2007, 165 days after receiving the submission on August 14, 2006.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K062354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2006 |
| Decision Date | January 26, 2007 |
| Days to Decision | 165 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 |