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510(k) Data Aggregation

    K Number
    K251581

    Validate with FDA (Live)

    Device Name
    Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
    Manufacturer
    Shenzhen Hingmed Medical Instrument Co., Ltd.
    Date Cleared
    2026-02-13

    (266 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    12 - 120
    Reference & Predicate Devices
    K151520
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Wearable Ambulatory Blood Pressure Monitor, model WBP-02A is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to measure systolic and diastolic pressure in individuals aged 12 years and older. The collected data can be transmitted to a PC via USB for healthcare professionals to review and analyze. This device is not intended for diabetic patients, pregnant women, or patients with arrhythmia. It is intended for prescription use only.

    Device Description

    The WBP-02A Ambulatory Blood Pressure Monitor from Hingmed Medical comprises a main unit, a cuff, a USB data cable, and PC analysis software. This compact and portable device is worn comfortably on the patient's upper arm. The cuff inflates to occlude the brachial artery and then gradually deflates. The device employs the oscillometric method to measure blood pressure and pulse parameters during the deflation phase, capturing the transition from blood flow occlusion to restoration. The main unit's internal memory can store up to 300 measurement records. Upon completion of the monitoring period, the data is transferred via the USB cable to a computer for comprehensive statistical analysis using the dedicated software.

    The ambulatory blood pressure monitor software has two components: embedded software and PC software.

    The embedded software runs on the main control unit, directing the monitor to take measurements and collect blood pressure data, which it sends to the PC software via USB. The PC software analyzes the data, generates charts for medical review, and can also configure the device—such as setting measurement intervals—and initiate readings.

    The PC software operates offline and does not replace any tasks performed by healthcare professionals.

    The device firmware does not include the calculation function for Mean Arterial Pressure (MAP), and the OLED screen on the host device does not display MAP values. The accompanying PC software can display the hourly average MAP value and its trend graph. MAP is calculated using the standard equivalent formula, as follows:

    Calculation Formula: MAP = (SBP + 2 x DBP) / 3
    Alternative expression: MAP = DBP + (1/3) x PP

    Where:

    • SBP = Systolic Blood Pressure
    • DBP = Diastolic Blood Pressure
    • PP = Pulse Pressure (SBP – DBP)

    Note on the Formula:
    The expression "MAP = (SBP + 2 x DBP) / 3" is mathematically equivalent to the standard MAP formula "DBP + 1/3 x (SBP – DBP)".

    AI/ML Overview

    N/A

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