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510(k) Data Aggregation

    K Number
    K253133

    Validate with FDA (Live)

    Date Cleared
    2026-02-13

    (141 days)

    Product Code
    Regulation Number
    870.1130
    Age Range
    12 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K221372

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Wrist Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of person older than twelve (12) years via non-invasive oscillometric technique in medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

    Device Description

    Wrist Blood Pressure Monitor, model: BPM-W1VL is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited.

    It measures blood pressure and pulse rate through inflating cuff which rounding the wrist of patients. The BPM-W1VL is small, portable and used at home or in medical facilities environment.

    The Wrist Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-W1VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD.

    Principle of operation: This product uses the Oscillometric Measuring method to detect blood pressure. When the cuff is fully inflated to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate. And Wrist circumference is 13.5-21.5 cm.

    AI/ML Overview

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