Cleared Traditional

Bariatric Heavy Duty Wheelchair (YJ-010B 20??DS; YJ-010B 20??DE; YJ-010B 20??DFS; YJ-010B 20??DFE;YJ-010B 20??ADS; YJ-010B 20??ADE; YJ-010B 20??ADFS; YJ-010B 20??ADFE; YJ-010B 22??DS; YJ-010B 22??DE; YJ-010B 22??DFS;YJ-010B 22??DFE; YJ-010B 22??ADS;YJ-010B 22??ADE; YJ-010B 22??ADFS; YJ-010B 22??ADFE; YJ-010B 24??DS; YJ-010B 24??DE; YJ-010B 24??DFS; YJ-010B 24??DFE; YJ-010B 24??ADS; YJ-010B 24??ADE; YJ-010B 22??ADFS; YJ-010B 24??ADFE)

K232199 · Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine

Sep 2023

Decision

52d

Days

Class 1

Risk

About This 510(k) Submission

K232199 is an FDA 510(k) clearance for the Bariatric Heavy Duty Wheelchair (YJ-010B 20??DS; YJ-010B 20??DE; YJ-010B 20??DFS; YJ-010B 20??DFE;YJ-010B 20??ADS; YJ-010B 20??ADE; YJ-010B 20??ADFS; YJ-010B 20??ADFE; YJ-010B 22??DS; YJ-010B 22??DE; YJ-010B 22??DFS;YJ-010B 22??DFE; YJ-010B 22??ADS;YJ-010B 22??ADE; YJ-010B 22??ADFS; YJ-010B 22??ADFE; YJ-010B 24??DS; YJ-010B 24??DE; YJ-010B 24??DFS; YJ-010B 24??DFE; YJ-010B 24??ADS; YJ-010B 24??ADE; YJ-010B 22??ADFS; YJ-010B 24??ADFE), a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Zhenjiang Assure Medical Equipment Co., Ltd. (Zhenjiang, CN). The FDA issued a Cleared decision on September 15, 2023, 52 days after receiving the submission on July 25, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K232199 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2023
Decision Date	September 15, 2023
Days to Decision	52 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.