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510(k) Data Aggregation

    K Number
    K003368
    Device Name
    ACROTHERM
    Manufacturer
    AQUARIUS MEDICAL CORP.
    Date Cleared
    2001-01-19

    (81 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    AQUARIUS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970367
    Device Name
    THERMO-STAT SYSTEM
    Manufacturer
    AQUARIUS MEDICAL CORP.
    Date Cleared
    1997-12-17

    (320 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    AQUARIUS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermo-STAT is designed to non-invasively treat hypothermic patients by rewarming their body core. This is accomplished with local application of negative pressure and a thermal load (heat) to a distal appendage.
    Device Description
    The Thermo-STAT is a non-invasive and portable body core warming device which provides a noninvasive technique to treat and prevent hypothermia. The Thermo-STAT's principle of action for counteracting hypothermia is to create a thermal pipeline between the skin and the body core. The Thermo-STAT functions by applying a combination of heat and pressure to only the distal aspect of an arm or leg. Using the Thermo-STAT, a thermal load is exchanged between the application site and the body core. Vasoconstriction in a hypothermic individual prevents superficial heat alone from effectively altering the body core temperature. The Thermo-STAT circumvents this "vasoconstrictive blockade" with a slight negative pressure (40-60mmHg) and enables a thermal load to be transferred directly and exclusively from a thermal heat pad to the body core via the bloodstream. Current means, such as forced air rewarming, fail to effectively overcome the "vasoconstrictive blockade."
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