Cleared Traditional

SPECIALTY CONTROLS INTERFACE

K913645 · Everest & Jennings, Inc. · Physical Medicine

Dec 1991

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K913645 is an FDA 510(k) clearance for the SPECIALTY CONTROLS INTERFACE, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Everest & Jennings, Inc. (Camarillo, US). The FDA issued a Cleared decision on December 17, 1991, 123 days after receiving the submission on August 16, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K913645 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 1991
Decision Date	December 17, 1991
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

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).