Cleared Traditional

INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91

K021680 · Invacare Corp. · Physical Medicine

Jun 2002

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K021680 is an FDA 510(k) clearance for the INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on June 18, 2002, 27 days after receiving the submission on May 22, 2002. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K021680 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2002
Decision Date	June 18, 2002
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

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).