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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K172895
Device Name AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819
Applicant
Ageless Health Industrial Co., Ltd.
3/F, A1 Bldg, Dongshen Sima Industrial Area,
#33 Shenbei Rd., Sima Village,
Dongguan,  CN 523000
Applicant Contact Victor Wan
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, #121 Science Rd., Guangzhou
Science Park
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/22/2017
Decision Date 06/18/2018
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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