Cleared Traditional

FOLDING WHEELCHAIR

K915108 · Guardian Products Co., Inc. · Physical Medicine

Jan 1992

Decision

61d

Days

Class 1

Risk

About This 510(k) Submission

K915108 is an FDA 510(k) clearance for the FOLDING WHEELCHAIR, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Guardian Products Co., Inc. (North Hollywood, US). The FDA issued a Cleared decision on January 13, 1992, 61 days after receiving the submission on November 13, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K915108 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 1991
Decision Date	January 13, 1992
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

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.