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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 K242714
Device Name Mobility Scooter (S-01); Mobility Scooter (S-02)
Applicant
Zhejiang Seedream Medical Equipment Co., Ltd.
Rm. 301, Bldg. A9, # 118, Xinyu Rd., Jinhua Intergrated
Science And Technology Industrial Park, Qinbin Subdistrict
Jinhua,  CN
Applicant Contact Jinxiang Zhao
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Luna Hu
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/10/2024
Decision Date 01/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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