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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 K253632
Device Name Manual Wheelchair (W50)
Applicant
Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.
#36 Danyan Rd.
Danyang,  CN
Applicant Contact Weixia Shi
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Shouqiu Xiang
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/19/2025
Decision Date 01/29/2026
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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