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510(k) Data Aggregation

    K Number
    K253228

    Validate with FDA (Live)

    Device Name
    YUWELL® Electronic Blood Pressure Monitor (YE650AR)
    Manufacturer
    Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
    Date Cleared
    2026-02-23

    (147 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    12 - 120
    Reference & Predicate Devices
    K200939
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is indicated for measuring blood pressure and pulse rate in patients older than 12 years. It is not suitable for neonates, pregnant individuals, or patients with pre-eclampsia. The device can be used at home or in a healthcare facility.

    Device Description

    YUWELL® Blood Pressure Monitor (Model: YE650AR) is a rechargeable lithium battery-powered, automatic, noninvasive, upper-arm blood pressure measurement system intended for use by adults. The YE650AR is designed for upper arm circumference ranging from 22 cm to 32cm (8.7 in to 12.5 in) or 22 cm to 45 cm (8.7 in to 17.7 in). The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During deflation, the cuff pressure is monitored, and pulse waveform data is captured. The pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.

    AI/ML Overview

    N/A

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