Cleared Traditional

Electric Wheelchair

K220827 · Foshan Dahao Medical Technology Co., Ltd. · Physical Medicine

Jul 2022

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K220827 is an FDA 510(k) clearance for the Electric Wheelchair, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Foshan Dahao Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on July 5, 2022, 105 days after receiving the submission on March 22, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K220827 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2022
Decision Date	July 05, 2022
Days to Decision	105 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).