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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K231801
Device Name MedHealth DVT compression Devices MHH900S/MHH900E
Applicant
Medhealth Medical Limited
701/101, Bldg. 24, Block B, Yuanshan Zone
Shangcun, Gongming
Shenzhen,  CN 518106
Applicant Contact Steven Jiang
Correspondent
Medhealth Medical Limited
701/101, Bldg. 24, Block B, Yuanshan Zone
Shangcun, Gongming
Shenzhen,  CN 518106
Correspondent Contact Steven Jiang
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/20/2023
Decision Date 12/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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