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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 K252817
Device Name Mobility Scooter (BC-MS310)
Applicant
Ningbo Baichen Medical Devices Co., Ltd.
Rm. 2101, #666 Taikang Middle Rd., Yinzhou District
Ningbo,  CN 315000
Applicant Contact Xiaolong Wu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ariel Xiang
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/04/2025
Decision Date 01/02/2026
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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