Cleared Traditional

TEMPEST ELECTRIC WHEELCHAIR

K904958 · Everest & Jennings, Inc. · Physical Medicine

Nov 1990

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K904958 is an FDA 510(k) clearance for the TEMPEST ELECTRIC WHEELCHAIR, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Everest & Jennings, Inc. (Camarillo, US). The FDA issued a Cleared decision on November 26, 1990, 21 days after receiving the submission on November 5, 1990. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K904958 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 1990
Decision Date	November 26, 1990
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—

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).