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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K252835
Device Name Electric Scooter (S202572J, S2060, M2089, S2050)
Applicant
Guangdong Prestige Technology Co., Ltd.
#8, Rd..1, 3rd Ind. District, Houjie Qiaotou, Houjie Town
Dongguan,  CN 523950
Applicant Contact Zhao Zhang
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plaza,
Shuixi Rd., Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/05/2025
Decision Date 12/23/2025
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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