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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 K261919
Device Name Multifunctional wheelchair (YJ-059)
Applicant
Zhenjiang Assure Medical Equipment Co., Ltd.
#799, Chuqiao Rd.
Zhenjiang,  CN
Applicant Contact Christine Dong
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/09/2026
Decision Date 09/16/2026
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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