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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 K261394
Device Name Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
Applicant
JOYTECH Healthcare Co., Ltd.
#502, Shunda Rd., Hangzhou, Zhejiang 311100, China
#365, Wuzhou Rd., Hangzhou, Zhejiang 311100, China
Hangzhou,  CN 311100
Applicant Contact Yingting Lan
Correspondent
JOYTECH Healthcare Co., Ltd.
#502, Shunda Rd., Hangzhou, Zhejiang 311100, China
#365, Wuzhou Rd., Hangzhou, Zhejiang 311100, China
Hangzhou,  CN 311100
Correspondent Contact Yingting Lan
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/29/2026
Decision Date 08/26/2026
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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