Cleared Traditional

MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR

K012167 · Invacare Corp. · Physical Medicine

Aug 2001

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K012167 is an FDA 510(k) clearance for the MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on August 1, 2001, 20 days after receiving the submission on July 12, 2001. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K012167 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2001
Decision Date	August 01, 2001
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IOR — Wheelchair, Mechanical
Device Class	Class I — General Controls
CFR Regulation	21 CFR 890.3850
Definition	A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.