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    K Number
    K252779

    Validate with FDA (Live)

    Device Name
    YUWELL® Electronic Blood Pressure Monitor (YE630CR)
    Manufacturer
    Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
    Date Cleared
    2026-03-05

    (184 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    12 - 120
    Reference & Predicate Devices
    K162092
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to measure blood pressure and pulse rate in patients over 12 years old with an upper-arm circumference ranging from 22 cm to 45 cm (8.7 in to 17.7 in). 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: YE630CR) is a rechargeable lithium battery-powered, automatic, noninvasive upper-arm blood pressure measuring system intended for over-the-counter (OTC) use. YE630CR is designed for people with upper arm circumference ranging from 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 by an air pump and it deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and the pulse waveform data is captured. The pulse waveform data is then further analyzed by software which determines pulse rate, as well as the systolic and diastolic blood pressures.

    AI/ML Overview

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