Cleared Traditional

BCW POWER ADVANTAGE WHEELCHAIR

K970743 · Wheelchairs of Kansas · Physical Medicine

Apr 1997

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K970743 is an FDA 510(k) clearance for the BCW POWER ADVANTAGE WHEELCHAIR, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Wheelchairs of Kansas (Ellis, US). The FDA issued a Cleared decision on April 30, 1997, 62 days after receiving the submission on February 27, 1997. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K970743 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	ITI — Wheelchair, Powered
Device Class	Class II — 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).