Cleared Traditional

STORM TDX POWER WHEELCHAIR

K023589 · Invacare Corp. · Physical Medicine

Nov 2002

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K023589 is an FDA 510(k) clearance for the STORM TDX 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 November 19, 2002, 25 days after receiving the submission on October 25, 2002. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K023589 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 2002
Decision Date	November 19, 2002
Days to Decision	25 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).