Product code LXJ
- Device name
- Interactive Rehabilitation Exercise Devices
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5360
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192474 | VERA | Reflexion Health, Inc. | 2019-10-10 |
| K182333 | Vera | Reflexion Health, Inc. | 2019-04-09 |
| K180880 | DARI Health | Scientific Analytics, Inc. | 2019-03-07 |
| K171547 | Qualisys Clinical System | Qualisys AB | 2018-08-02 |
| K173931 | MindMotion(TM) GO | Mindmaze SA | 2018-05-17 |
| K172882 | UINCARE HOME | Uincare Corp. | 2018-05-10 |
| K162748 | MindMotionPRO | Mindmaze SA | 2017-04-24 |
| K163245 | Virtual Occupational Therapy Application (VOTA) | Barron Associates, Inc. | 2017-02-28 |
| K151955 | YuGo System | Biogaming , Ltd. | 2016-02-05 |
| K150462 | Vera | Reflexion Health, Inc. | 2015-10-30 |
| K151446 | Recovr Rehabilitation System | Recovr,Inc | 2015-09-18 |
| K143034 | Jintronix | Jintronix, Inc. | 2015-04-22 |
| K131660 | SMART (SMART-D, SMART-DX) | Bts S.P.A. | 2014-04-17 |
| K130847 | JINTRONIX REHABILITATION SYSTEM (JRS) | Jintronix, Inc. | 2014-02-28 |
| K091000 | KNEEKG | Emovi | 2009-10-26 |
| K033514 | CODA CX1 MOTION ANALYSIS SYSTEM | Charnwood Dynamics , Ltd. | 2004-01-06 |
| K030714 | PEAK MOTUS | Peak Performance Technologies, Inc. | 2003-05-16 |
| K982425 | CODA MPX30 MOTION ANALYSIS SYSTEM | Pinsco Inc. Dba B & L Engineering | 1998-10-07 |
| K943430 | CERVICAL FUNCTION INDICATOR | Whiplash Analysis, Inc. | 1995-03-13 |
| K923033 | THE TRACKER | Epm Information Systems, Inc. | 1993-06-01 |
| K924512 | LIDO V-TAK | Loredan Biomedical, Inc. | 1993-05-12 |
| K911416 | ELITE SYSTEM | Gfb Intl. Trading, Inc. | 1991-06-06 |
| K890074 | SPINETRAK | Motion Analysis Corp. | 1989-02-03 |
| K890075 | FOOTTRAK | Motion Analysis Corp. | 1989-02-03 |
| K890076 | ORTHOTRAK | Motion Analysis Corp. | 1989-02-03 |
| K880631 | 2K-QDA MOTION/GAIT ANALYSIS SYSTEM | Human Performance Technologies, Inc. | 1988-04-21 |
| K811172 | VICON | Oxford Medilog, Inc. | 1981-06-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199874027012 | Jintronix | Ludica Health Inc. | 2026-04-20 |
| B179SEVBUN050 | SMART | BTS SPA | 2024-12-27 |
| B179SEVBUN260 | SMART | BTS SPA | 2024-12-27 |
| B179SEVBUN090 | SMART | BTS SPA | 2024-12-27 |
| B179SEVBUN020 | SMART | BTS SPA | 2024-12-20 |
| B179SDXEVO1 | SMART | BTS SPA | 2023-09-06 |
| 00627843933236 | KneeKG system | Emovi Inc | 2022-03-23 |
| 00885556803868 | ARIA | Smith & Nephew, Inc. | 2021-04-20 |
| 07300009074518 | Qualisys Clinical System | Qualisys AB | 2020-09-02 |
| 00860001498400 | VERA | REFLEXION HEALTH, INC. | 2019-06-30 |
| 05707480042548 | Sleepmate / SparepartBody Position Band | Ambu A/S | 2019-01-10 |
| 05707480042661 | Body Position Sensor - Alice 3 | Ambu A/S | 2019-01-07 |
| 05707480042807 | VIASYS QDC CABLE BROWN | Ambu A/S | 2019-01-07 |
| 05707480042777 | VIASYS QDC CABLE GREEN | Ambu A/S | 2019-01-07 |
| 05707480042715 | SleepmateBody Position Sensor - Alice 5 | Ambu A/S | 2019-01-03 |
| 05707480042685 | SleepmateDC Body Position Sensor - Cadwell | Ambu A/S | 2019-01-03 |
| 05707480042609 | SleepmateDC Body Position Sensor - Viasys | Ambu A/S | 2019-01-03 |
| 05707480042555 | SleepmateAC Body Position Sensor | Ambu A/S | 2019-01-03 |
| 05707480042500 | SleepmateDC Low Impedance Kit | Ambu A/S | 2019-01-03 |
| 05707480042272 | SleepmateAC Body Position Sensor Kit | Ambu A/S | 2019-01-03 |
| 05707480042838 | SleepmateBody Position - Cadwell | Ambu A/S | 2019-01-03 |
| 05707480043477 | SleepmateBody Position Sensor | Ambu A/S | 2019-01-03 |
| 03760272650019 | MindMotion™ GO | NeuroXtherapeutics SA | 2018-05-28 |
| 03760272650002 | MindMotion PRO | NeuroXtherapeutics SA | 2017-08-01 |
| 00863090000400 | SaeboVR | VIRTUAL THERAPY SOLUTIONS, LLC. | 2017-06-01 |
| B548VICONVEROSYSTEM0 | VICON | VICON MOTION SYSTEMS LIMITED | 2017-04-18 |
| B548VICONVANTAGESYSTEM0 | VICON | VICON MOTION SYSTEMS LIMITED | 2017-04-18 |
| B548VICONTSERIESSYSTEM0 | VICON | VICON MOTION SYSTEMS LIMITED | 2017-04-18 |
| B548BONITASYSTEM0 | VICON | VICON MOTION SYSTEMS LIMITED | 2017-04-18 |
| B179SDX | SMART | BTS SPA | 2017-02-12 |