Cleared Traditional

K041190 - A&I POWER WHEELCHAIR, PC-401

K041190 is an FDA 510(k) clearance for A&I POWER WHEELCHAIR, manufactured by Well Success Biotech, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K041190 · Well Success Biotech, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
19d
Days
Class 2
Risk

K041190 is an FDA 510(k) clearance for the A&I POWER WHEELCHAIR, PC-401. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Well Success Biotech, Inc. (Hsin Chu City, TW). The FDA issued a Cleared decision on May 25, 2004 after a review of 19 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 - K041190

510(k) Number K041190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2004
Decision Date May 25, 2004
Days to Decision 19 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
97d faster than avg
Panel avg: 116d · This submission: 19d
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 585
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K041190.
PRO WALKER PL-200 POWER WHEELCHAIR
K041336 · Pro Walker, Inc. · Jul 2004
INVACARE 3G TARSYS
K033819 · Invacare Corp. · Jun 2004
GOLDEN SPYDER, MODEL GS-300
K041341 · Golden Technologies, Inc. · Jun 2004
POWERED WHEELCHAIR
K033142 · Nats Corp. · May 2004
NOMAD FROM DYNAMIS MOBILITY LTD.
K040457 · Dynamis Mobility , Ltd. · May 2004
SINON POWER WHEELCHAIR, SN-P401
K040320 · Sinon Corporation · Mar 2004
K041190 · A&I POWER WHEELCHAIR, PC-401
Download PDF FDA Summary Well Success Biotech,…