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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 K251458
Device Name Electric Wheelchair (DH01168)
Applicant
Foshan Dahao Medical Technology Co., Ltd.
Bldg. 1, 2nd Floor Of Bldg. 2, 3rd Floor Of Bldg.2
3rd Floor Of Bldg.2, Bldg. 3, 4, 5, 6, 7, #9
Foshan,  CN
Applicant Contact Yixie Bao
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg.,
1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Luna Hu
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/12/2025
Decision Date 01/15/2026
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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