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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 K261075
Device Name Manual Wheelchair (MS01);Manual Wheelchair (MA01)
Applicant
GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
#39, Baozhu E. Rd., Huangpu Town
Zhongshan,  CN 528400
Applicant Contact Sally Peng
Correspondent
GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
#39, Baozhu E. Rd., Huangpu Town
Zhongshan,  CN 528400
Correspondent Contact Sally Peng
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/01/2026
Decision Date 06/22/2026
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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