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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 K253307
Device Name Electric wheelchair
Applicant
Foshan Dahao Medical Technology Co., Ltd.
Bldg. 1, 2" Floor Of Bldg.2, 3"" Floor Of Bldg. 2,
Bldg.3, 4,5,6,7, #9 Of Fanye Rd., Lepingtown, Sanshui
Foshan,  CN
Applicant Contact Zehui Huang
Correspondent
Foshan Dahao Medical Technology Co., Ltd.
Bldg. 1, 2" Floor Of Bldg.2, 3"" Floor Of Bldg. 2,
Bldg.3, 4,5,6,7, #9 Of Fanye Rd., Lepingtown, Sanshui
Foshan,  CN
Correspondent Contact Klem Hou
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/29/2025
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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