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510(k) Data Aggregation

    K Number
    K222160
    Device Name
    GUS610 Blood pressure monitor
    Manufacturer
    Globalcare Medical Technology Co., Ltd.
    Date Cleared
    2022-11-22

    (125 days)

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

    Globalcare Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Globalcare GUS610 Automatic Blood Pressure Monitor is indicated for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 42 cm.
    Device Description
    The Globalcare GUS610 Blood Pressure Monitor is an automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate. The device is powered by batteries or by a mains-connected power supply. The Globalcare GUS610 Blood Pressure Monitor comprises the following parts: Blood pressure monitor main device x1, Upper arm cuff x1, 1.5 V LR03 AAA batteries x4, Storage bag x1, Instructions for use x1, 100-240Vac 50/60Hz power supply (optional) with USB cable x1. None of the parts included with the device are supplied in a sterile condition. The Globalcare GUS610 Blood Pressure Monit is an electronic unit incorporating a screen that displays results and other information relevant to device operation. The device is powered by batteries or by a mains-connected power adapter and is designed for home ('OTC') use. The clinical outputs from the GUS610 Blood Pressure Monitor are: Systolic pressure (mm Hq), Diastolic pressure (mm Hq), Pulse rate (1/min), Cardiac arrhythmia (Irregular heartbeat (IHB)) symbol, Risk indicator (WHO color scale), Hemodynamic Rest Condition (HSD) indication. The device operates on the oscillometric method: pressure sensors on the cuff are used to capture pulse waves during constricted blood flow and the device then computes the results for display by means of an algorithm which analyses the pressures transmitted during arterial oscillations that occur during cuff inflation. Irreqular heartbeat (IHB) is detected by measuring the interval time between each heartbeat and comparing these values with the average heartbeat interval (heartbeat per minutes shown on the display). If the difference between any heartbeat interval and the average is higher or lower than 25 %, the device shows the irregular heartbeat (IHB) symbol on the display. The pulse rate is determined by calculating the frequency of the cuff, which are cardiac synchronous. The GUS610 is controlled by software which calculates the blood pressure (diastolic and pulse rate by the oscillometric method. To do this, it also controls the pneumatic components to inflate the cuff (with a pump), holds the cuff pressure, and then deflates the cuff (by means of a solenoid valve). The software collects the relevant data from the pressure sensor during inflation. The software also drives the LCD display, from which the user can read the result of the blood pressure and pulse rate measurements and undertakes the Hemodynamic Rest Condition (HSD) detection calculations, and reports whether any irregular heartbeat is occurring.
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    K Number
    K192633
    Device Name
    GUS831 Compressor Nebulizer
    Manufacturer
    Globalcare Medical Technology Co., Ltd.
    Date Cleared
    2020-05-01

    (221 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Globalcare Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use.
    Device Description
    GUS831 Compressor Nebulizer is a portable aerosol nebulizer electronically powered by an external power adapter and by an internal rechargeable lithium polymer battery. The compressed air, created by the membrane pump of the device, flows into the nebulizer container kit. The air pressure forced the liquid through the nozzle where it is atomized against a plate within the container. The device is equipped with a mouthpiece to easily delivery the medical aerosol.
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