510(k) K062354
K062354 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "VECTRA GENISYS VMS FR". The FDA issued a decision of Substantially Equivalent on Jan 26, 2007. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Encore Medical L.P. has 81 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 26, 2007
- Date Received
- Aug 14, 2006
- 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
- 510(k)