Cleared Traditional

Power wheelchair

K251159 · Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine
Dec 2025
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K251159 is an FDA 510(k) clearance for the Power wheelchair, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Zhenjiang Assure Medical Equipment Co., Ltd. (Zhenjiang, CN). The FDA issued a Cleared decision on December 22, 2025, 251 days after receiving the submission on April 15, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number K251159 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2025
Decision Date December 22, 2025
Days to Decision 251 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).

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