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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 K263257
Device Name Electrically Powered Wheelchair (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.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Andrew Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/17/2026
Decision Date 10/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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