Cleared Traditional

MCC-MIV ONE 2 ONE SOFTWARE

K010364 · Invacare Corp. · Physical Medicine

Mar 2001

Decision

43d

Days

Class 2

Risk

About This 510(k) Submission

K010364 is an FDA 510(k) clearance for the MCC-MIV ONE 2 ONE SOFTWARE, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on March 22, 2001, 43 days after receiving the submission on February 7, 2001. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K010364 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2001
Decision Date	March 22, 2001
Days to Decision	43 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).