Cleared Traditional

S.P.F. PREMIER 2 WHEELCHAIR

K904152 · Everest & Jennings, Inc. · Physical Medicine

Sep 1990

Decision

12d

Days

Class 1

Risk

About This 510(k) Submission

K904152 is an FDA 510(k) clearance for the S.P.F. PREMIER 2 WHEELCHAIR, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Everest & Jennings, Inc. (Camarillo, US). The FDA issued a Cleared decision on September 19, 1990, 12 days after receiving the submission on September 7, 1990. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K904152 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 1990
Decision Date	September 19, 1990
Days to Decision	12 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.