Cleared Traditional

XTERRA GT POWER WHEELCHAIR

K012909 · Invacare Corp. · Physical Medicine

Oct 2001

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K012909 is an FDA 510(k) clearance for the XTERRA GT POWER WHEELCHAIR, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on October 24, 2001, 55 days after receiving the submission on August 30, 2001. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K012909 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2001
Decision Date	October 24, 2001
Days to Decision	55 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).