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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 K200978
Device Name Electric Wheelchair (Model: S7110)
Applicant
Dongguan Prestige Sporting Goods Co., Ltd.
3rd Ind. District, Qiaotou Area, Houjie Town
Dongguan,  CN 523950
Applicant Contact Zhang Zhao
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.,
Huangpu District
Guangzhou,  CN 510663
Correspondent Contact Cassie Lee
Regulation Number890.3860
Classification Product Code
ITI  
Date Received04/13/2020
Decision Date 04/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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