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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 K260319
Device Name K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))
Applicant
Zhenjiang Assure Medical Equipment Co., Ltd.
#799, Chuqiao Rd., Zhenjiang City, Jiangsu Province,China
Zhenjiang,  CN
Applicant Contact Ying Mei
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 Received01/30/2026
Decision Date 03/31/2026
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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