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510(k) Data Aggregation

    K Number
    K250979
    Date Cleared
    2025-10-15

    (198 days)

    Product Code
    Regulation Number
    870.5900
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K101589

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    When used with Thermogard XP® or Thermogard HQ™ console: Temperature reduction in patients 2 years and older where clinically indicated, e.g. in hyperthermic patients.

    Device Description

    The Thermogard HQ™ Temperature Management System and Thermogard XP® Temperature Management System (herein referred as Thermogard Surface System) consists of a Thermogard Console (TGXP or TGHQ), a Surface Start-Up Kit (SSUK) and a Surface Pad whose function is to provide therapeutic cooling to a patient. The Thermogard Surface System including the VitalTemp™ Universal Pad as a surface pad, is designed to provide therapeutic cooling to patient's 2 years and older. The Surface System delivers treatment to the patient by recirculating cold fluid through a single-use surface pad (non-sterile) and its associated disposable tubing set, the Surface Start-Up Kit (SSUK). The fluid is the intermediate heat-transfer medium between the Thermogard Console and the surface pad.

    The VitalTemp™ Universal Pad is a non-sterile disposable product. It is available in one size and can either be placed under, over the patient or used as a wrap. The VitalTemp™ is manufactured and processed using identical materials, internal parts, and processes as the Thermogard™ Vest, with the only difference being the size and shape of the surface pad.

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