Cleared Special

KIDS ROCK 3 CHAIR

K111739 · Pride Mobility Products Corp. · Physical Medicine

Aug 2011

Decision

52d

Days

Class 1

Risk

About This 510(k) Submission

K111739 is an FDA 510(k) clearance for the KIDS ROCK 3 CHAIR, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Pride Mobility Products Corp. (Exeter, US). The FDA issued a Cleared decision on August 12, 2011, 52 days after receiving the submission on June 21, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K111739 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2011
Decision Date	August 12, 2011
Days to Decision	52 days
Submission Type	Special
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

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.