Cleared Traditional

K143034 - Jintronix

K143034 is an FDA 510(k) clearance for Jintronix, manufactured by Jintronix, Inc.. The device is a Class 2 Physical Medicine device with product code LXJ cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K143034 · Jintronix, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
182d
Days
Class 2
Risk

K143034 is an FDA 510(k) clearance for the Jintronix. Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Jintronix, Inc. (Seattle, US). The FDA issued a Cleared decision on April 22, 2015 after a review of 182 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K143034

510(k) Number K143034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2014
Decision Date April 22, 2015
Days to Decision 182 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 116d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXJ Device Classification - Class 2, Special Controls

Product Code LXJ Interactive Rehabilitation Exercise Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Axsource Consulting, Inc.
Navneet Sekhon

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LXJ Interactive Rehabilitation Exercise Devices

All 22
Devices cleared under the same product code (LXJ) and FDA review panel - the closest regulatory comparables to K143034.
YuGo System
K151955 · Biogaming , Ltd. · Feb 2016
Vera
K150462 · Reflexion Health, Inc. · Oct 2015
Recovr Rehabilitation System
K151446 · Recovr,Inc · Sep 2015
SMART (SMART-D, SMART-DX)
K131660 · Bts S.P.A. · Apr 2014
JINTRONIX REHABILITATION SYSTEM (JRS)
K130847 · Jintronix, Inc. · Feb 2014
KNEEKG
K091000 · Emovi · Oct 2009
K143034 · Jintronix
Download PDF FDA Summary Jintronix, Inc.