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510(k) Data Aggregation

    K Number
    K061959
    Device Name
    MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310
    Date Cleared
    2006-08-22

    (42 days)

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

    MYTECH TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor,, Model HPL-301, HPL-302, HPL-310, 180310 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to be 7"-15".
    Device Description
    Basically, the subject device and the predicated device are the same in intended use, technological characteristics, power supply, LCD display, range, accuracy, and operating environments, dimensions, weight, and storage environments. The minor differences are the memory and display layout. That means the predicate device has 60 memory capacities and the new devices have 60 memory capacities. Besides, the new devices add 3 colors LED warming lights for the visional appearance. The main differences of the new devices are: - HPL-301 is the representative model of the new devices; - HPL-302 is same as the HPL-301, add USB port for PC-LINK function; ● - HPL-310 is same as the HPL-301, add voice prompt function for arm; ● - 180310 is all the same as HPL-310, just using another model name. ●
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    K Number
    K041228
    Device Name
    MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200
    Date Cleared
    2004-05-17

    (7 days)

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

    MYTECH TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" – 7.75".
    Device Description
    Basically, the subject device and the predicated device are the same in intended use, technological characteristics, power supply, LCD display, range, accuracy, and operating environments, memory, dimensions, weight, and storage environments. The only difference is the display layout.
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    K Number
    K030221
    Device Name
    MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR
    Date Cleared
    2003-07-25

    (185 days)

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

    MYTECH TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to be 7"-15".
    Device Description
    noninvasive blood pressure measurement system
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    K Number
    K030561
    Device Name
    MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A
    Date Cleared
    2003-05-09

    (77 days)

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

    MYTECH TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" - 7.75".
    Device Description
    Not Found
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