Cleared Traditional

K042652 - TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR

K042652 is an FDA 510(k) clearance for TAIWAN KING STRONG TC 04 MECHANICALWHEE..., manufactured by Taiwan King Strong Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K042652 · Taiwan King Strong Co., Ltd. · Physical Medicine device
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Nov 2004
Decision
37d
Days
Class 1
Risk

K042652 is an FDA 510(k) clearance for the TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Taiwan King Strong Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on November 4, 2004 after a review of 37 days - a notably fast clearance 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: 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 - K042652

510(k) Number K042652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2004
Decision Date November 04, 2004
Days to Decision 37 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
79d faster than avg
Panel avg: 116d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

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 465
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K042652.
CIE FOLDAWAY WHEELCHAIR
K050345 · Carlsbad International Export, Inc. · Mar 2005
LERADO, COSCO
K050290 · Lerado Oversea Ltd. Twn Branch (Bvi) · Feb 2005
WHEELCHAIR, MODEL 8500-II
K043332 · Cycling and Health Tech. Industry R&D Center · Dec 2004
LITESTREAM 500E
K042444 · Pride Mobility Products Corp. · Oct 2004
VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
K042401 · American Track Roadsters, Inc. · Oct 2004
CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251
K042304 · Spectris Technologies, Inc. · Sep 2004
K042652 · TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR
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