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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 K260237
Device Name Mobility Scooter (X-12, X-14, X-17)
Applicant
Wuyi Aichi Industry and Trade Co., Ltd.
Southeast Industrial Zone, Duan Village, Shuxi St.,
Wuyi City
Jinhua,  CN
Applicant Contact Wei Lu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Kiwi Xu
Regulation Number890.3800
Classification Product Code
INI  
Date Received01/26/2026
Decision Date 04/22/2026
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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