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510(k) Data Aggregation

    K Number
    K121720
    Device Name
    WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
    Manufacturer
    Date Cleared
    2012-08-20

    (69 days)

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

    WELKINS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WElkins EMT Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated. The WElkins ICU Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated and monitoring of patient temperature.
    Device Description
    The WElkins EMT/ICU Temperature Management System is a thermoregulatory device that reduces and/or maintains patient body temperature within a range of 30℃ (86°F) to 37°C (98.6°F). The System delivers temperature-controlled coolant ranging between 5°C (41°F) and 25°C (77°F) from one of two Conditioning Units (EMT or ICU) to a patientcontacting Cooling Pad, resulting in heat exchange between the coolant and the patient. The EMT Conditioning Unit is a lightweight, battery-powered pack for use in the field; patient temperature is controlled manually, by modulating the temperature of coolant circulated to the Cooling Pad, and must be monitored regularly during treatment. The ICU Conditioning Unit is an enhanced, microprocessor-driven version of the EMT Conditioning Unit designed for use in the hospital setting: it features a touchscreen graphical user interface and automatic patient temperature control, in addition to the same core hydraulic and pneumatic cooling system used in the EMT Conditioning Unit. A patient temperature probe connected to the ICU Conditioning Unit provides biofeedback to an internal control algorithm, which automatically modulates coolant temperature to achieve a patient target temperature determined by the clinician. The Cooling Pad comes in Universal and Head-Neck configurations. The safety and effectiveness of the Cooling Pad has not been demonstrated for treatment of stroke or head trauma, and is not indicated for use in their treatment.
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