ONBO ELECTRONIC (SHENZHEN) CO. LTD.

FDA Device Registration & Listing · SHENZHEN Guangdong, CN · Registration 9680225

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9680225
FEI Number
3003010579
Entity Name
ONBO ELECTRONIC (SHENZHEN) CO. LTD.
City/State/Country
SHENZHEN Guangdong, CN
Establishment Address
No.138, Huasheng Road, Langkou Community, Dalang Street, Longhua District, SHENZHEN Guangdong --, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MICROLIFE CORP. (Owner Number: 8020605)
Owner / Operator Contact Address
9F, 431, RuiGuang Road, NeiHu, TAIPEI, TW-TPE 11492, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K153450
PMA Number
N/A

All Registered Proprietary Names

PERSONAL RHYTHM CLOCK LIQUID CRYSTAL RHYTHM THERMOMETER Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-10-29
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-08-21
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-11-23
FQZ Thermometer, Clinical Color Change General Hospital Class 1 880.2900 1983-07-21
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2012-01-31
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2011-12-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-07-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-04-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2018-10-15
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2010-11-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-03-20
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2016-02-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-01-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-02-21
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-12-08
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2010-06-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2009-06-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2009-05-27
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-11-26
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-08-31
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-02-21
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-07-24
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-07-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-08-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-06-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-05-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-08-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-16
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-08-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-09-16
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-07-22
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-16
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-09-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-11-16
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

ALAN P. SCHWARTZ Business: MDI CONSULTANTS, INC. Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

MICROLIFE CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3016867013 ONFU electronics Co., LTD. Trang Bom Dong Nai, VN
3003993690 MICROLIFE INTELLECTUAL PROPERTY GMBH Widnau Sankt Gallen, CH
8020605 MICROLIFE CORP. TAIPEI, TW

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680225. Last updated year: 2026. Please use registration number 9680225 when referencing this establishment in official correspondence.
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