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
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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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 116d · 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 Consultant

Tuv Sud America, Inc.
ALEXANDER SCHAPOVALOV

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 - ITI Wheelchair, Powered

All 456
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K140204.
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Quickie, Zippie
K142457 · Sunrise Medical (Us), LLC · Dec 2014
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K130982 · Lerado Global (Macao Commercial Offshore) Limited · Feb 2014
ZX-I POWER ADD ON
K123769 · Spinergy, Inc. · May 2013

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.