510(k) K162748
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2017
- Date Received
- September 30, 2016
- 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