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510(k) Data Aggregation

    K Number
    K253142

    Validate with FDA (Live)

    Date Cleared
    2026-01-09

    (106 days)

    Product Code
    Regulation Number
    870.1130
    Age Range
    22 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. 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 which can be driven by dry batteries. 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 proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate.

    This blood pressure monitor has the memory function of 60 groups of measuring data of two people, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.

    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.

    The subject device includes model MJ1DS/MJ1D/MJ3D/MJ5D/MJ6D/MJ8D/RN3D/MJ4D/RN1D/RN2D. These models are identical in terms of software design, cuff type, measurement range and function, principle, the core algorithm of the software, the key components. The schematic circuit diagrams are identical in all models. The PCB layout are identical in all models because of different appearance such as structure, buttons layout.

    AI/ML Overview

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