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510(k) Data Aggregation

    K Number
    K242568
    Device Name
    Wrist Blood Pressure Monitor (OHMS11, OHMS12)
    Manufacturer
    Shenzhen Zhongkemingwang Telecommunications Software Corp.
    Date Cleared
    2025-01-30

    (154 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Zhongkemingwang Telecommunications Software Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.0 cm to 21.0 cm.
    Device Description
    The Wrist Blood Pressure Monitor is a reusable, active, non-sterile, non-invasive and non-implantable device for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.0 cm to 21.0 cm. It is a home-use device prohibited from use in MRI (magnetic resonance imaging) environment. This device has the systolic and diastolic display features. The device is of the watch type and powered by a rechargeable lithium-polymer battery. An AC adapter is used for charging the device, but the device cannot be operated while charging. The device wrist cuff inflates using an integral pump, and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 300mmHg. Product includes device (preinstalled with a strap and large-sized cuff: 16.6-21.0cm), strap with a medium-sized cuff: 13.0-16.5cm, wrist measuring tape, charging base (with the power cable). The product functional configurations of OHMS11 and OHMS12 are completely identical, and the difference between the two is reflected in the color (OHMS11 is the dark gray color, OHMS12 is the champagne color).
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