Cleared Traditional

RUNAROUND

K862405 · Everest & Jennings, Inc. · Physical Medicine

Jul 1986

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K862405 is an FDA 510(k) clearance for the RUNAROUND, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Everest & Jennings, Inc. (Camarillo, US). The FDA issued a Cleared decision on July 15, 1986, 20 days after receiving the submission on June 25, 1986. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K862405 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 1986
Decision Date	July 15, 1986
Days to Decision	20 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).