Cleared Traditional

K140204 - JWX-2

K140204 is an FDA 510(k) clearance for JWX-2, manufactured by Yamaha Motor Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K140204 · Yamaha Motor Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
213d
Days
Class 2
Risk

K140204 is an FDA 510(k) clearance for the JWX-2. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Yamaha Motor Co., Ltd. (Hamamatsu, Shizuoka, JP). The FDA issued a Cleared decision on August 28, 2014 after a review of 213 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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.

View all Yamaha Motor Co., Ltd. devices

FDA 510(k) Submission Details - K140204

510(k) Number K140204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2014
Decision Date August 28, 2014
Days to Decision 213 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 115d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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 Peers - ITI Wheelchair, Powered

All 221
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K140204.
HEARTWAY Electrically Powered Wheelchair P27
K142783 · Heartway Medical Products Co., Ltd. · Jun 2015
HEARTWAY Electrically Powered Wheelchairs
K142731 · Heartway Medical Products Co., Ltd. · Feb 2015
TDX SP2 POWER WHEECHAIR
K141783 · Invacare Corporation · Jan 2015
HEARTWAY POWER WHEELCHAIR
K132856 · Heartway Medical Products Co., Ltd. · Jul 2014
HEARTWAY POWER CHAIR, P23
K100327 · Heartway Medical Products Co., Ltd. · Mar 2010
HEARTWAY LIGHTWEIGHT POWER CHAIR, P15
K071005 · Heartway Medical Products Co., Ltd. · May 2007