Electric Wheelchair (AL-208S-063)

FDA 510(k) K253340 · Zhongshan A&J Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK253340

Submission

Device name
Electric Wheelchair (AL-208S-063)
Applicant
Zhongshan A&J Medical Equipment Co., Ltd.
Zhongshan, CN
Received
September 30, 2025
Decision date
April 3, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITI – Wheelchair, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3860
Specialty
Physical Medicine

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…

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Questions and answers

When was Electric Wheelchair (AL-208S-063) cleared by the FDA?

Electric Wheelchair (AL-208S-063) (K253340) received a 510(k) decision of Substantially Equivalent on April 3, 2026, 185 days after the submission was received.

What is the product code of K253340?

The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.