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510(k) Data Aggregation

    K Number
    K040911
    Device Name
    VITALHEAT
    Date Cleared
    2004-06-22

    (75 days)

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

    DYNATHERM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VitalHeat™ is designed to Non-Invasively treat hypothermic patients by warming their body core. This is achieved by local application of negative pressure and thermal load (heat) to a distal appendage.
    Device Description
    The Dynatherm Medical, Inc. VitalHeat™ - Warming Mitt - Control Unit The VitalHeat™ is a compact, thermal warming device for use in health care facilities to help patients recover from the discomfort and consequences of lowered core temperature. The device utilizes a technology, which combines sub-atmospheric pressure (SAP) and a heating element on one heat tooknology, which cornent design is to be utilized on a hand). The combination of sub-atmospheric pressure and a heating element allow for the maximum transfer of heat through the heat exchange prosoulature. The compact design allows for minimum coverage of the patient (hand), which should not impede standard patient care and/o full body access.
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