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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 K252813
Device Name Electrical Scooter (SM4226)
Applicant
Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.
# 26, Guangfu Rd., Xiaolan Town
Zhongshan,  CN 528414
Applicant Contact Ke-Min Jen
Correspondent
Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.
# 26, Guangfu Rd., Xiaolan Town
Zhongshan,  CN 528414
Correspondent Contact Ke-Min Jen
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/04/2025
Decision Date 03/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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