Cleared Traditional

BCW 600 POWER WHEELCHAIR

K945047 · Wheelchairs of Kansas · Physical Medicine

Aug 1995

Decision

301d

Days

Class 2

Risk

About This 510(k) Submission

K945047 is an FDA 510(k) clearance for the BCW 600 POWER 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 August 11, 1995, 301 days after receiving the submission on October 14, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K945047 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 14, 1994
Decision Date	August 11, 1995
Days to Decision	301 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).