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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K254141
Device Name Manual Wheelchair (DY01903(2))
Applicant
Guangdong Dayang Medical Technology Co., Ltd.
Xingxian Development Zone, Changhongling Industrial Park
(2nd Phase), Shishan, Nanhai District
Foshan,  CN 528234
Applicant Contact Xueqiong Zhang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Andrew Wang
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/22/2025
Decision Date 05/21/2026
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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