The following data is part of a premarket notification filed by Valmed, Sa with the FDA for Powered Muscle Stimulator.
| Device ID | K112148 |
| 510k Number | K112148 |
| Device Name: | POWERED MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | VALMED, SA AVE DE TOURBILLON 34 Sion, Valais, CH Ch 1950 |
| Contact | Carl Magnell |
| Correspondent | Carl Magnell VALMED, SA AVE DE TOURBILLON 34 Sion, Valais, CH Ch 1950 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-27 |
| Decision Date | 2012-04-30 |
| Summary: | summary |