Cleared Traditional

K970743 - BCW POWER ADVANTAGE WHEELCHAIR

K970743 is an FDA 510(k) clearance for BCW POWER ADVANTAGE WHEELCHAIR, manufactured by Wheelchairs of Kansas. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K970743 · Wheelchairs of Kansas · Physical Medicine device
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Apr 1997
Decision
62d
Days
Class 2
Risk

K970743 is an FDA 510(k) clearance for the BCW POWER ADVANTAGE WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Wheelchairs of Kansas (Ellis, US). The FDA issued a Cleared decision on April 30, 1997 after a review of 62 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.

View all Wheelchairs of Kansas devices

FDA 510(k) Submission Details - K970743

510(k) Number K970743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1997
Decision Date April 30, 1997
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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 287
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K970743.
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K972563 · Mechanical Application Designs, Inc. · Aug 1997
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K970521 · Motion Concepts · Mar 1997
HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND
K954131 · Hoveround Corp. · Jun 1996