Cleared Traditional

WHEELCHAIR, MECHANICAL

K885330 · Kaye Products, Inc. · Physical Medicine

Feb 1989

Decision

37d

Days

Class 1

Risk

About This 510(k) Submission

K885330 is an FDA 510(k) clearance for the WHEELCHAIR, MECHANICAL, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Kaye Products, Inc. (Durham, US). The FDA issued a Cleared decision on February 3, 1989, 37 days after receiving the submission on December 28, 1988. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K885330 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 1988
Decision Date	February 03, 1989
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—

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.