Cleared Traditional

K021592 - PHFW-10

K021592 is an FDA 510(k) clearance for PHFW-10, manufactured by Pihsiang Machinery Mfg. Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K021592 · Pihsiang Machinery Mfg. Co., Ltd. · Physical Medicine device
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Jul 2002
Decision
61d
Days
Class 2
Risk

K021592 is an FDA 510(k) clearance for the PHFW-10. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Pihsiang Machinery Mfg. Co., Ltd. (Neodesha, US). The FDA issued a Cleared decision on July 15, 2002 after a review of 61 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 - K021592

510(k) Number K021592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2002
Decision Date July 15, 2002
Days to Decision 61 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
55d faster than avg
Panel avg: 116d · This submission: 61d
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 504
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K021592.
C.T.M. POWER CHAIR, MODEL HS-2800
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