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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 K200568
Device Name B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
Applicant
B&J Manufacturing , Ltd.
Rm. 701&101, Bldg. 24, Block B, Yuanshan Industrial Zone
Gongming
Shenzhen,  CN 518106
Applicant Contact Billy Yu
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Rm. 1713a, 17f, Black A, Time Sq., Xili Town
Shenzhen,  CN 518055
Correspondent Contact Fu Ailing
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/04/2020
Decision Date 07/10/2020
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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