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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, counter-pulsating, external
510(k) Number K191955
Device Name Enhanced External Counter Pulsation Device Plus Omay-A
Applicant
Omay(Guangzhou)Med Technologies Co., Ltd.
Room 302,3F, No. 600-1, Guangshan 2nd Road, Tianhe
Guangzhou,  CN
Applicant Contact Peixian Su
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
No. A415, Block A, NanShan Medical Devices Industrial Park
Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.5225
Classification Product Code
DRN  
Date Received07/22/2019
Decision Date 08/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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