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510(k) Data Aggregation

    K Number
    K030018
    Device Name
    MHS 7000
    Manufacturer
    MICRO HEALTH SYSTEMS INC.
    Date Cleared
    2003-03-26

    (83 days)

    Product Code
    LHQ
    Regulation Number
    884.2980
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO HEALTH SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MHS 7000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. The MHS 7000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her assessment of the patient's medical condition and requirements. The patient populations include all age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use.
    Device Description
    The MHS 7000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body. The MHS 7000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.
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    K Number
    K021956
    Device Name
    MHS MED LIGHT 1000
    Manufacturer
    MICRO HEALTH SYSTEMS INC.
    Date Cleared
    2002-08-13

    (61 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO HEALTH SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro Health Systems, MHS MED LIGHT 1000 is a device which helps to temporarily increase local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains through the use of heat applied in a non-contact manner.
    Device Description
    The Micro Health Systems, MHS MED LIGHT 1000 is a device which helps to temporarily increase local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains through the use of heat applied in a non-contact manner. Aiming means adjustable by users from the heat ceramic filament in which there is no hazard for contacting high temperature lamps. An adjustable timer control for safety functions is also incorporated into the MHS MED LIGHT 1000. The Micro Health System MHS MED LIGHT 1000 cooling method is related to temperature of the enclosure, and the enclosure, and the enclosure temperatures of the three devices listed in the comparison table are assured. According to the different wattages and the maximum temperatures, we also know the ceramic type lamp of the AP-2018 is more efficient that the other two lamps. The maximum temperatures for these three devices listed in the comparison table are above 100 degrees Fahrenheit, and can reach the intended results. The timer controls and the continuous intensity controls exist on the MHS MED LIGHT 1000. The user can control the timer function and intensity control the receiving heat amount, thus assuming the safety level.
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    K Number
    K011981
    Device Name
    MHS 5000
    Manufacturer
    MICRO HEALTH SYSTEMS INC.
    Date Cleared
    2001-09-05

    (72 days)

    Product Code
    LHQ
    Regulation Number
    884.2980
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO HEALTH SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MHS 5000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body in the settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. The MHS 5000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her assessment of the patient's medical condition and requirements. The patient population is not limited to pediatric and neonatal. The device is for providing thermal images of the human body.
    Device Description
    The MHS 5000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body. The MHS 5000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.
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