LXJ — Interactive Rehabilitation Exercise Devices Class II
FDA product code LXJ covers "Interactive Rehabilitation Exercise Devices", a Class II medical device regulated under 21 CFR 890.5360. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LXJ
- Device Class
- Class II
- Regulation Number
- 890.5360
- Submission Type
- 510(k)
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K192474 | Reflexion Health | VERA | Oct 10, 2019 |
| K182333 | Reflexion Health | Vera | Apr 9, 2019 |
| K180880 | Scientific Analytics | DARI Health | Mar 7, 2019 |
| K171547 | Qualisys | Qualisys Clinical System | Aug 2, 2018 |
| K173931 | Mindmaze | MindMotion(TM) GO | May 17, 2018 |
| K172882 | Uincare | UINCARE HOME | May 10, 2018 |
| K162748 | Mindmaze | MindMotionPRO | Apr 24, 2017 |
| K163245 | Barron Associates | Virtual Occupational Therapy Application (VOTA) | Feb 28, 2017 |
| K151955 | Biogaming | YuGo System | Feb 5, 2016 |
| K150462 | Reflexion Health | Vera | Oct 30, 2015 |
| K151446 | Recovr | Recovr Rehabilitation System | Sep 18, 2015 |
| K143034 | Jintronix | Jintronix | Apr 22, 2015 |
| K131660 | Bts | SMART (SMART-D, SMART-DX) | Apr 17, 2014 |
| K130847 | Jintronix | JINTRONIX REHABILITATION SYSTEM (JRS) | Feb 28, 2014 |
| K091000 | Emovi | KNEEKG | Oct 26, 2009 |
| K033514 | Charnwood Dynamics | CODA CX1 MOTION ANALYSIS SYSTEM | Jan 6, 2004 |
| K030714 | Peak Performance Technologies | PEAK MOTUS | May 16, 2003 |
| K982425 | Pinsco Inc. Dba B And L Engineering | CODA MPX30 MOTION ANALYSIS SYSTEM | Oct 7, 1998 |
| K943430 | Whiplash Analysis | CERVICAL FUNCTION INDICATOR | Mar 13, 1995 |
| K923033 | Epm Information Systems | THE TRACKER | Jun 1, 1993 |