Cleared Traditional

K142731 - HEARTWAY Electrically Powered Wheelchairs

K142731 is the FDA 510(k) clearance for HEARTWAY Electrically Powered Wheelchairs by Heartway Medical Products Co., Ltd.. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K142731 · Heartway Medical Products Co., Ltd. · Physical Medicine device
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Feb 2015
Decision
157d
Days
Class 2
Risk

K142731 is an FDA 510(k) clearance for the HEARTWAY Electrically Powered Wheelchairs. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Heartway Medical Products Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on February 27, 2015 after a review of 157 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 Heartway Medical Products Co., Ltd. devices

Submission Details

510(k) Number K142731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2014
Decision Date February 27, 2015
Days to Decision 157 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
42d slower than avg
Panel avg: 115d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 172
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K142731.
SupaChair Powered Wheelchair
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K023589 · Invacare Corp. · Nov 2002