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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 K260145
Device Name YJ-K1K2 Wheelchair (YJ-013F)
Applicant
Zhenjiang Assure Medical Equipment Co., Ltd.
#297, Chuqiao Rd.
Zhenjiang City,  CN 212016
Applicant Contact Mei Ying
Correspondent
Shanghai Jiushun Enterprise Management Technology Service Co
15 Floor,25 Floor,Bao An Tower,#800,Dongfang Rd.
Shanghai,  CN 200122
Correspondent Contact Eric Shi
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/20/2026
Decision Date 09/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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