510(k) K131660
K131660 is an FDA 510(k) premarket notification submitted by Bts S.P.A. for the device "SMART (SMART-D, SMART-DX)". The FDA issued a decision of Substantially Equivalent on April 17, 2014. The device falls under product code LXJ (Interactive Rehabilitation Exercise Devices), a Class II device regulated under 21 CFR 890.5360. Bts S.P.A. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2014
- Date Received
- June 6, 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