Cleared Traditional

WALKERTALKER

K933207 · Prentke Romich Co. · Physical Medicine

Mar 1994

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K933207 is an FDA 510(k) clearance for the WALKERTALKER, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Prentke Romich Co. (Wooster, US). The FDA issued a Cleared decision on March 28, 1994, 270 days after receiving the submission on July 1, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K933207 FDA.gov
FDA Decision	Cleared SN
Date Received	July 01, 1993
Decision Date	March 28, 1994
Days to Decision	270 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).