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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 K252590
Device Name Powered Mobility Scooter (PMS105, GUT177, GCAT047)
Applicant
Intradin (Shanghai) Machinery Co., Ltd.
# 118, Duhui Rd., Minhang District
Shanghai,  CN
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 Received08/15/2025
Decision Date 11/21/2025
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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