Cleared Traditional

K173313 - SupaChair Powered Wheelchair: COMBI 18

K173313 is the FDA 510(k) clearance for SupaChair Powered Wheelchair: COMBI 18 by Eurogreen International, Inc.. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K173313 · Eurogreen International, Inc. · Physical Medicine device
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Feb 2018
Decision
117d
Days
Class 2
Risk

K173313 is an FDA 510(k) clearance for the SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Eurogreen International, Inc. (Chang-Hua County, CN). The FDA issued a Cleared decision on February 13, 2018 after a review of 117 days - within the typical 510(k) review window.

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 Eurogreen International, Inc. devices

Submission Details

510(k) Number K173313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2017
Decision Date February 13, 2018
Days to Decision 117 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
2d slower than avg
Panel avg: 115d · This submission: 117d
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 K173313.
Wu's Powered Wheelchair
K181163 · Wu'S Tech Co., Ltd. · Feb 2019
Invacare TDX SP2-HD with Captain's Seat
K182946 · Invacare Corporation · Dec 2018
Action Trackchair
K181908 · Action Manufacturing, Inc. · Dec 2018
SupaChair Powered Wheelchair
K173315 · Eurogreen International, Inc. · Feb 2018
Invacare® TDX® SP2 Power Wheelchair
K170507 · Invacare Corporation · Jul 2017
HEARTWAY Electrically Powered Wheelchair P27
K142783 · Heartway Medical Products Co., Ltd. · Jun 2015