Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070467
    Device Name
    HEALTH MASK
    Manufacturer
    Date Cleared
    2007-04-17

    (60 days)

    Product Code
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLAR WRAP LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Health Mask is intended to moderate the expected physiological response to cold (i.e., increase in blood pressure). For diagnosed hypertensives 18 years or older.
    Device Description
    The Health mask is a device worn by an individual outdoors when the air is cold. It is designed to retain the heat and moisture exhaled by the wearer and warm and humidify the inhaled cold air. The wearer breathes through a thermal medium which retains and returns the heat and moisture in the breathed air. The Thermal medium is placed inside a fabric mask which the wearer places over their mouth and nose. The mask is held in place with an elastic band.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1