LXJ
27 FDA 510(k) clearances · Product code
182 daysmedian time to decision
339 days90th percentile
27clearances measured
FDA profile
- Official device name
- Interactive Rehabilitation Exercise Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5360
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VERA (K192474) | Reflexion Health, Inc. | 2019-10-10 |
| Vera (K182333) | Reflexion Health, Inc. | 2019-04-09 |
| DARI Health (K180880) | Scientific Analytics, Inc. | 2019-03-07 |
| Qualisys Clinical System (K171547) | Qualisys AB | 2018-08-02 |
| MindMotion(TM) GO (K173931) | Mindmaze SA | 2018-05-17 |
| UINCARE HOME (K172882) | Uincare Corp. | 2018-05-10 |
| MindMotionPRO (K162748) | Mindmaze SA | 2017-04-24 |
| Virtual Occupational Therapy Application (VOTA) (K163245) | Barron Associates, Inc. | 2017-02-28 |
| YuGo System (K151955) | Biogaming , Ltd. | 2016-02-05 |
| Vera (K150462) | Reflexion Health, Inc. | 2015-10-30 |
| Recovr Rehabilitation System (K151446) | Recovr,Inc | 2015-09-18 |
| Jintronix (K143034) | Jintronix, Inc. | 2015-04-22 |
| SMART (SMART-D, SMART-DX) (K131660) | Bts S.P.A. | 2014-04-17 |
| JINTRONIX REHABILITATION SYSTEM (JRS) (K130847) | Jintronix, Inc. | 2014-02-28 |
| KNEEKG (K091000) | Emovi | 2009-10-26 |
| CODA CX1 MOTION ANALYSIS SYSTEM (K033514) | Charnwood Dynamics , Ltd. | 2004-01-06 |
| PEAK MOTUS (K030714) | Peak Performance Technologies, Inc. | 2003-05-16 |
| CODA MPX30 MOTION ANALYSIS SYSTEM (K982425) | Pinsco Inc. Dba B & L Engineering | 1998-10-07 |
| CERVICAL FUNCTION INDICATOR (K943430) | Whiplash Analysis, Inc. | 1995-03-13 |
| THE TRACKER (K923033) | Epm Information Systems, Inc. | 1993-06-01 |
| LIDO V-TAK (K924512) | Loredan Biomedical, Inc. | 1993-05-12 |
| ELITE SYSTEM (K911416) | Gfb Intl. Trading, Inc. | 1991-06-06 |
| ORTHOTRAK (K890076) | Motion Analysis Corp. | 1989-02-03 |
| SPINETRAK (K890074) | Motion Analysis Corp. | 1989-02-03 |
| FOOTTRAK (K890075) | Motion Analysis Corp. | 1989-02-03 |
| 2K-QDA MOTION/GAIT ANALYSIS SYSTEM (K880631) | Human Performance Technologies, Inc. | 1988-04-21 |
| VICON (K811172) | Oxford Medilog, Inc. | 1981-06-16 |
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Every clearance here is in the API, with alerts when new ones post.