FDA.reportPublic FDA data

510(k) K222153

Device
Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
Applicant
Microlife Intellectual Property GmbH
510(k) number
K222153
Product code
DXN
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-03
Date received
2022-07-20
Regulation
870.1130
Classification name
System, Measurement, Blood-Pressure, Non-Invasive
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gerhard Frick
Address
Espenstrasse 139 Widnau CH 9443 9443

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254000Happy Health Blood Pressure MonitorHappy Health, Inc.2026-09-03
K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.2026-08-31
K261394Arm-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)JOYTECH Healthcare Co., Ltd.2026-08-26
K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.2026-08-13
K261061BP Go (BPP-855)Wellvii, Inc.2026-08-13
K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation2026-07-23
K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.2026-07-23
K253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.2026-06-18
K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH2026-06-16
K253059Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)Tournicare Pty, Ltd.2026-06-15
K253124Upper arm electronic blood pressure monitor (XB-01)Shenzhen Ziqing Medical Equipment Co., Ltd.2026-06-03
K253570Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd.2026-05-20
K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)Shenzhen Urion Technology Co., Ltd.2026-05-14
K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC2026-05-06
K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)Joytech Healthcare Co. , Ltd.2026-04-28