510(k) K063642
K063642 is an FDA 510(k) premarket notification submitted by Fuji Dynamics Limited for the device "FD EMS, MODEL # D-FJ30E". The FDA issued a decision of Substantially Equivalent on December 13, 2007. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Fuji Dynamics Limited has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2007
- Date Received
- December 7, 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