Cleared Special

JAZZY FRONTIE

K092961 · Pride Mobility Products Corp. · Physical Medicine

Oct 2009

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K092961 is an FDA 510(k) clearance for the JAZZY FRONTIE, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Pride Mobility Products Corp. (Exeter, US). The FDA issued a Cleared decision on October 23, 2009, 28 days after receiving the submission on September 25, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K092961 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2009
Decision Date	October 23, 2009
Days to Decision	28 days
Submission Type	Special
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

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).