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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 K231320
Device Name Zhenjiang Assure Mechanical Wheelchair,model:K1
Applicant
Zhenjiang Assure Medical Equipment Co., Ltd.
#297, Chuqiao Rd.,
Zhenjiang City,  CN
Applicant Contact Eric Shi
Correspondent
Zhenjiang Assure Medical Equipment Co., Ltd.
#297, Chuqiao Rd.,
Zhenjiang City,  CN
Correspondent Contact Eric Shi
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/08/2023
Decision Date 06/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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