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510(k) Data Aggregation

    K Number
    K251143

    Validate with FDA (Live)

    Date Cleared
    2025-12-19

    (249 days)

    Product Code
    Regulation Number
    870.1130
    Age Range
    18 - 73
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arm Blood Pressure Monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy.

    Device Description

    The subject device, Arm Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy.

    The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.

    The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x60 sets of measurement values can be stored automatically. The unit also calculates an average reading based on the values of the latest 3 times measurement.

    This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.

    No operation for 1 minute the device will shut down automatically.

    AI/ML Overview

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