LXJ · Interactive Rehabilitation Exercise Devices
Physical Medicine · 21 CFR 890.5360 · Class 2
Overview
| Product Code | LXJ |
|---|---|
| Device Name | Interactive Rehabilitation Exercise Devices |
| Regulation | 21 CFR 890.5360 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.
Classification Rationale
Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192474 | VERA | Reflexion Health, Inc. | Oct 10, 2019 | SESE |
| K182333 | Vera | Reflexion Health, Inc. | Apr 9, 2019 | SESE |
| K180880 | DARI Health | Scientific Analytics, Inc. | Mar 7, 2019 | SESE |
| K171547 | Qualisys Clinical System | Qualisys AB | Aug 2, 2018 | SESE |
| K173931 | MindMotion(TM) GO | Mindmaze SA | May 17, 2018 | SESE |
| K172882 | UINCARE HOME | Uincare Corp. | May 10, 2018 | SESE |
| K162748 | MindMotionPRO | Mindmaze SA | Apr 24, 2017 | SESE |
| K163245 | Virtual Occupational Therapy Application (VOTA) | Barron Associates, Inc. | Feb 28, 2017 | SESE |
| K151955 | YuGo System | Biogaming , Ltd. | Feb 5, 2016 | SESE |
| K150462 | Vera | Reflexion Health, Inc. | Oct 30, 2015 | SESE |
| K151446 | Recovr Rehabilitation System | Recovr,Inc | Sep 18, 2015 | SESE |
| K143034 | Jintronix | Jintronix, Inc. | Apr 22, 2015 | SESE |
| K131660 | SMART (SMART-D, SMART-DX) | Bts S.P.A. | Apr 17, 2014 | SESE |
| K130847 | JINTRONIX REHABILITATION SYSTEM (JRS) | Jintronix, Inc. | Feb 28, 2014 | SESE |
| K091000 | KNEEKG | Emovi | Oct 26, 2009 | SESE |
| K033514 | CODA CX1 MOTION ANALYSIS SYSTEM | Charnwood Dynamics , Ltd. | Jan 6, 2004 | SESE |
| K030714 | PEAK MOTUS | Peak Performance Technologies, Inc. | May 16, 2003 | SESE |
| K982425 | CODA MPX30 MOTION ANALYSIS SYSTEM | Pinsco Inc. Dba B & L Engineering | Oct 7, 1998 | SESE |
| K943430 | CERVICAL FUNCTION INDICATOR | Whiplash Analysis, Inc. | Mar 13, 1995 | SESE |
| K923033 | THE TRACKER | Epm Information Systems, Inc. | Jun 1, 1993 | SESE |
Top Applicants
- Motion Analysis Corp. — 3 clearances
- Reflexion Health, Inc. — 3 clearances
- Jintronix, Inc. — 2 clearances
- Mindmaze SA — 2 clearances
- Barron Associates, Inc. — 1 clearance
