Cleared Traditional

Wheelchair (K163352) - FDA 510(k) Clearance

Class I Physical Medicine device.

K163352 · Kunshan Hi-Fortune Health Products Co., Ltd. · Physical Medicine device
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Jul 2017
Decision
240d
Days
Class 1
Risk

K163352 is an FDA 510(k) clearance for the Wheelchair. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Kunshan Hi-Fortune Health Products Co., Ltd. (Kunshan, CN). The FDA issued a Cleared decision on July 28, 2017 after a review of 240 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 Kunshan Hi-Fortune Health Products Co., Ltd. devices

Submission Details

510(k) Number K163352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2016
Decision Date July 28, 2017
Days to Decision 240 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 115d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 53
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K163352.
Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
K181090 · Invacare Corporation · Nov 2018
AST Model MA012 and MS019 Rehab Wheelchair
K181795 · Sichuan Ast Medical Equipment Co., Ltd. · Sep 2018
Athena 190
K173360 · Medical Rehab Products, LLC · May 2018
Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair
K162621 · Invacare Corporation · Apr 2017
Kuschall Champion Manual Wheelchair
K162686 · Invacare Corporation · Dec 2016
Kuschall K-Series Attract Manual Wheelchair
K162692 · Invacare Corporation · Dec 2016