Product Code: LXJ FDA class 2 21 CFR 890.5360

Interactive Rehabilitation Exercise Devices

Physical Medicine

Interactive Rehabilitation Exercise Devices (product code LXJ) are physical medicine instruments that use interactive technology, such as biofeedback or computer-assisted guidance, to facilitate therapeutic exercise and rehabilitation following injury or surgery. Regulated under 21 CFR 890.5360 and classified as a Class 2 device, they require a 510(k) premarket notification and fall under the Physical Medicine specialty. The devices are not flagged as implants or life-sustaining, and are not eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: LXJ
Device Class: FDA class 2
Regulation Number: 890.5360
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K192474	VERA	Oct 10, 2019	Substantially Equivalent	Reflexion Health, Inc.
K182333	Vera	Apr 09, 2019	Substantially Equivalent	Reflexion Health, Inc.
K180880	DARI Health	Mar 07, 2019	Substantially Equivalent	Scientific Analytics, Inc.
K171547	Qualisys Clinical System	Aug 02, 2018	Substantially Equivalent	Qualisys AB
K173931	MindMotion(TM) GO	May 17, 2018	Substantially Equivalent	Mindmaze SA
K172882	UINCARE HOME	May 10, 2018	Substantially Equivalent	Uincare Corp.
K162748	MindMotionPRO	Apr 24, 2017	Substantially Equivalent	Mindmaze SA
K163245	Virtual Occupational Therapy Application (VOTA)	Feb 28, 2017	Substantially Equivalent	Barron Associates, Inc.
K151955	YuGo System	Feb 05, 2016	Substantially Equivalent	Biogaming , Ltd.
K150462	Vera	Oct 30, 2015	Substantially Equivalent	Reflexion Health, Inc.
K151446	Recovr Rehabilitation System	Sep 18, 2015	Substantially Equivalent	Recovr,Inc
K143034	Jintronix	Apr 22, 2015	Substantially Equivalent	Jintronix, Inc.
K131660	SMART (SMART-D, SMART-DX)	Apr 17, 2014	Substantially Equivalent	Bts S.P.A.
K130847	JINTRONIX REHABILITATION SYSTEM (JRS)	Feb 28, 2014	Substantially Equivalent	Jintronix, Inc.
K091000	KNEEKG	Oct 26, 2009	Substantially Equivalent	Emovi
K033514	CODA CX1 MOTION ANALYSIS SYSTEM	Jan 06, 2004	Substantially Equivalent	Charnwood Dynamics , Ltd.
K030714	PEAK MOTUS	May 16, 2003	Substantially Equivalent	Peak Performance Technologies, Inc.
K982425	CODA MPX30 MOTION ANALYSIS SYSTEM	Oct 07, 1998	Substantially Equivalent	Pinsco Inc. Dba B & L Engineering
K943430	CERVICAL FUNCTION INDICATOR	Mar 13, 1995	Substantially Equivalent	Whiplash Analysis, Inc.
K923033	THE TRACKER	Jun 01, 1993	Substantially Equivalent	Epm Information Systems, Inc.
K924512	LIDO V-TAK	May 12, 1993	Substantially Equivalent	Loredan Biomedical, Inc.
K911416	ELITE SYSTEM	Jun 06, 1991	Substantially Equivalent	Gfb Intl. Trading, Inc.
K890076	ORTHOTRAK	Feb 03, 1989	Substantially Equivalent	Motion Analysis Corp.
K890075	FOOTTRAK	Feb 03, 1989	Substantially Equivalent	Motion Analysis Corp.
K890074	SPINETRAK	Feb 03, 1989	Substantially Equivalent	Motion Analysis Corp.
K880631	2K-QDA MOTION/GAIT ANALYSIS SYSTEM	Apr 21, 1988	Substantially Equivalent	Human Performance Technologies, Inc.
K811172	VICON	Jun 16, 1981	Substantially Equivalent	Oxford Medilog, Inc.