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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 K250027
Device Name Powered Mobility Scooter
Applicant
Intradin (Shanghai) Machinery Co., Ltd.
# 118, Duhui Rd., Minhang District
Shanghai,  CN Shanghai
Applicant Contact Mark Li
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ariel Xiang
Regulation Number890.3800
Classification Product Code
INI  
Date Received01/06/2025
Decision Date 02/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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