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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 K242975
Device Name Mobility Scooter (Model X-01, X-02)
Applicant
Wuyi Aichi Industry & Trade Co., Ltd.
Yongwu Rd., Southeast Industrial Zone
Wuyi City,  CN 321200
Applicant Contact Wei Lyu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/26/2024
Decision Date 05/07/2025
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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