Cleared Traditional

YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR

K120526 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Physical Medicine

Mar 2012

Decision

15d

Days

Class 1

Risk

About This 510(k) Submission

K120526 is an FDA 510(k) clearance for the YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Northbrook, US). The FDA issued a Cleared decision on March 8, 2012, 15 days after receiving the submission on February 22, 2012. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K120526 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2012
Decision Date	March 08, 2012
Days to Decision	15 days
Submission Type	Traditional
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.