Cleared Traditional

BCW ADVANTAGE WHEELCHAIR

K961514 · Wheelchairs of Kansas · Physical Medicine

May 1996

Decision

18d

Days

Class 1

Risk

About This 510(k) Submission

K961514 is an FDA 510(k) clearance for the BCW ADVANTAGE WHEELCHAIR, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Wheelchairs of Kansas (Ellis, US). The FDA issued a Cleared decision on May 7, 1996, 18 days after receiving the submission on April 19, 1996. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K961514 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 1996
Decision Date	May 07, 1996
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

Product Code	IOR — Wheelchair, Mechanical
Device Class	Class I — 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.