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510(k) Data Aggregation

    K Number
    K170545
    Device Name
    Automatic Wrist Bluetooth Blood Pressure Monitor
    Manufacturer
    Truly Instrument Ltd.
    Date Cleared
    2017-11-21

    (270 days)

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

    Truly Instrument Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Truly Automatic Wrist Bluetooth Blood Pressure Monitor DW702, DW703 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The devices' features include irregular pulse rhythm detection during measurement, and will display an alert signal with the reading when irregular heartbeat is detected. The devices' features include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
    Device Description
    Truly Automatic Wrist Bluetooth Blood Pressure Monitor DW702, DW703 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method". The main components of the Truly Automatic Wrist Blood Pressure Monitor Dw series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to Wrist circumference approximately between 135 and 220 mm, includes the inflatable bladder and nylon shell. All models of the Wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA alkaline batteries. The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%. The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.
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