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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K253980
Device Name Electrically Powered Wheelchair (Model YC-01)
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 200122
Correspondent Contact Ariel Xiang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/12/2025
Decision Date 03/27/2026
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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