Cleared Traditional

K033031 - TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR

K033031 is an FDA 510(k) clearance for TAIWAN KING STRONG TC 03 MECHANICAL WHE..., 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 67-day FDA review.

K033031 · Taiwan King Strong Co., Ltd. · Physical Medicine device
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Dec 2003
Decision
67d
Days
Class 1
Risk

K033031 is an FDA 510(k) clearance for the TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR. 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 December 2, 2003 after a review of 67 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.

View all Taiwan King Strong Co., Ltd. devices

FDA 510(k) Submission Details - K033031

510(k) Number K033031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date December 02, 2003
Days to Decision 67 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
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 184
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K033031.
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