Cleared Traditional

Power wheelchair (Model: JMPW-01W)

K232783 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Physical Medicine

Jan 2024

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K232783 is an FDA 510(k) clearance for the Power wheelchair (Model: JMPW-01W), a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on January 19, 2024, 130 days after receiving the submission on September 11, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K232783 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2023
Decision Date	January 19, 2024
Days to Decision	130 days
Submission Type	Traditional
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).