510(k) K130847
K130847 is an FDA 510(k) premarket notification submitted by Jintronix, Inc. for the device "JINTRONIX REHABILITATION SYSTEM (JRS)". The FDA issued a decision of Substantially Equivalent on Feb 28, 2014. The device falls under product code LXJ (Interactive Rehabilitation Exercise Devices), a Class II device regulated under 21 CFR 890.5360. Jintronix, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 28, 2014
- Date Received
- Mar 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
- 510(k)