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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 K252828
Device Name Manual Wheelchair (W47)
Applicant
Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.
#36 Danyan Rd.
Danyang,  CN
Applicant Contact Weixia Shi
Correspondent
Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.
#36 Danyan Rd.
Danyang,  CN
Correspondent Contact Ariel Xiang
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/05/2025
Decision Date 12/05/2025
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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