510(k) K130847
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2014
- Date Received
- March 26, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interactive Rehabilitation Exercise Devices
- Device Class
- Class II
- Regulation Number
- 890.5360
- Review Panel
- PM
- Submission Type