Cleared Traditional

K033097 - TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02

K033097 is an FDA 510(k) clearance for TAIWAN KING STRONG POWERED WHEELCHAIR, manufactured by Taiwan King Strong Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K033097 · Taiwan King Strong Co., Ltd. · Physical Medicine device
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Nov 2003
Decision
44d
Days
Class 2
Risk

K033097 is an FDA 510(k) clearance for the TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Taiwan King Strong Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on November 12, 2003 after a review of 44 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K033097

510(k) Number K033097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date November 12, 2003
Days to Decision 44 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 116d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 589
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K033097.
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01
K033100 · Taiwan King Strong Co., Ltd. · Dec 2003
POWERED WHEELCHAIR, MODEL FR168W
K033370 · Freerider Corp · Nov 2003
Y.E.S POWERED WHEELCHAIR. T180
K032512 · Yeou Eir Shuen Machinery Co., Ltd. · Nov 2003
K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT
K033263 · Track Corporation · Oct 2003
F-10 FOLDING POWER CHAIR
K032441 · Wheelchair & Scooter Express · Oct 2003
F-11 FOLDING POWER CHAIR
K032440 · Wheelchair & Scooter Express · Sep 2003
K033097 · TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02
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