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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 K253600
Device Name Scooter (YD-03)
Applicant
Yurob Rehabilitation Medical Co., Ltd.
#93 Dianxing Rd., Dianshanhu Town
Kunshan,  CN
Applicant Contact Daoping Pan
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Ariel Xiang
Regulation Number890.3800
Classification Product Code
INI  
Date Received11/18/2025
Decision Date 06/03/2026
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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