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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K253340
Device Name Electric Wheelchair (AL-208S-063)
Applicant
Zhongshan A&J Medical Equipment Co., Ltd.
3 Shenghui S. Rd., Nantou Town
Zhongshan,  CN
Applicant Contact Yong Li
Correspondent
Zhongshan A&J Medical Equipment Co., Ltd.
3 Shenghui S. Rd., Nantou Town
Zhongshan,  CN
Correspondent Contact Yong Li
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/30/2025
Decision Date 04/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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