510(k) K112148
K112148 is an FDA 510(k) premarket notification submitted by Valmed, SA for the device "POWERED MUSCLE STIMULATOR". The FDA issued a decision of Substantially Equivalent on April 30, 2012. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Valmed, SA has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2012
- Date Received
- July 27, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type