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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 K252275
Device Name Electric Scooter (DDF100)
Applicant
Zhejiang Nysin Medical Co., Ltd.
# 305 Jiulong N. Rd., Dongcheng District, Yongkang
Jinhua,  CN 321000
Applicant Contact Xiaoying Zhang
Correspondent
Orscene (Shanghai) Medical Technology Co., Ltd.
Rm. 118, Bldg. 20, # 1-42, Lane 83, Hongxiang N. Rd.
Lingang New Zone, China (Shanghai) Pilot Free Trade Zone
Shanghai,  CN
Correspondent Contact Lord Guo
Regulation Number890.3800
Classification Product Code
INI  
Date Received07/22/2025
Decision Date 01/29/2026
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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