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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 K261571
Device Name Manual Wheelchair (H008, PCK7)
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Yunyang Industrial Park Danyang City
#1 Baisheng Rd. Development Zone
Danyang Jiangsu,  CN 212300
Applicant Contact Fang (Fawn) Zhang
Correspondent
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Yunyang Industrial Park Danyang City
#1 Baisheng Rd. Development Zone
Danyang Jiangsu,  CN 212300
Correspondent Contact Fang (Fawn) Zhang
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/12/2026
Decision Date 08/06/2026
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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