Cleared Traditional

Electric wheelchair (W1,W3)

K253707 · Shenzhen Zhimahuaerkai Technology Co., Ltd. · Physical Medicine

Feb 2026

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K253707 is an FDA 510(k) clearance for the Electric wheelchair (W1,W3), a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Shenzhen Zhimahuaerkai Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 24, 2026, 92 days after receiving the submission on November 24, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K253707 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2025
Decision Date	February 24, 2026
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

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).