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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 K220827
Device Name Electric Wheelchair
Applicant
Foshan Dahao Medical Technology Co., Ltd.
Bldg. 1, 2nd Floor Of Bldg. 2, 3rd Floor Of Bldg. 2
Bldg. 3,4,5,6,7, #9 Of Fanye Rd.
Foshan,  CN 528137
Applicant Contact Bao Yi Xie
Correspondent
Guangdong Jianda Medical Technology Co., Ltd.
906 Rm., Longxiang Garden,
Tianhe District
Guangzhou,  CN 510000
Correspondent Contact Iris Fung
Regulation Number890.3860
Classification Product Code
ITI  
Date Received03/22/2022
Decision Date 07/05/2022
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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