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510(k) Data Aggregation

    K Number
    K171668
    Device Name
    Bluetooth blood pressure monitor
    Manufacturer
    Date Cleared
    2018-02-26

    (266 days)

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

    Visiomed Group SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BW-BA1 Bluetooth Blood Pressure Monitor is intended to be used to measure systolic and diastolic blood pressure and heart rate from the upper arm with arm circumference ranging from 8.7 inches (approx.22 cm to 42 cm) using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a "IHB" warning signal with readings. The intended patient population of the device is only adult population aged 18 or older at home, not applied to the other populations such as neonatal baby. It cannot be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The device cannot be used by pregnant patients or patients suffering from pre-eclampsia.
    Device Description
    BW-BA1 Bluetooth Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method during inflating @ 3~8mmHg/second from about 30mmHg by inflating a cuff on the upper arm. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. An irregular heartbeat rhythm is defined as rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure. BW-BA1 Bluetooth Blood Pressure Monitor without any display component achieves its function by integrating the device with a collateral device iPhone, iPad with a specific mobile app to constitute a complete blood pressure measurement system. And the new device connects the mobile platform with the mobile app through Bluetooth 4.0. The operational principle is based on oscillometric and pressure sensor technology, it can calculate the systolic and diastolic blood pressure, and the measurement results can be classified by the function of blood pressure classification indicator according to the classification rule developed by WHO. The BW-BA1 is powered by a rechargeable Lithium battery. The device has an ON/START button for starting the measuring and stopping the measuring at any time when measuring.
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    K Number
    K112929
    Device Name
    THERMOFLASH(TM) INFRARED THERMOMETER
    Manufacturer
    Date Cleared
    2011-10-18

    (15 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIOMED GROUP SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ThermoFlash™ is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contacting to human body. It can be used by consumers in household environment and doctor in clinic as reference.
    Device Description
    ThermoFlash™, including LX-26, LX-261, LX-260 and LX-260T, are handheld electronic thermometer that measures the body temperature based on the infrared sensor technology. All objects emit energy by radiation. The intensity of this energy depends on the temperature of the object. ThermoFlash™ is, therefore, able to measure the temperature of a person by the energy the person emits. Infrared sensor can sense the infrared emissions from the human body (forehead) and environment; then the electronic signal will be transferred by AD module to the digital signal and displayed on the LCD screen. - A LX-26 is a thermometer with basic temperature measurement functions. - A LX-260 is an advanced model to LX-26, which provides three additional keys which allow user to select the measurement directly; - ア LX-261 is an advanced model to LX-260, which provides a rechargeable station base and inner Li rechargeable battery which can be recharged; - LX-260T is an advanced model, which provides voice indicating of measured temperature.
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