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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 K252588
Device Name Mobility Scooter (T5)
Applicant
Zhejiang Taotao Vehicle Co., Ltd.
#10 Xinyuan Rd., Xinbi St., Jinyun County
Lishui City, Zhejiang Province, China
Lishui,  CN
Applicant Contact Guangqin Yao
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/15/2025
Decision Date 12/04/2025
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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