Cleared Traditional

Manual Wheelchair (Model W28)

K200466 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Physical Medicine

Jun 2021

Decision

474d

Days

Class 1

Risk

About This 510(k) Submission

K200466 is an FDA 510(k) clearance for the Manual Wheelchair (Model W28), a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on June 14, 2021, 474 days after receiving the submission on February 26, 2020. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K200466 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2020
Decision Date	June 14, 2021
Days to Decision	474 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.