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510(k) Data Aggregation

    K Number
    K030281
    Device Name
    CRYOTRON 2 CRYOTHERAPY DEVICE
    Manufacturer
    CRYONIC MEDICAL NORTH AMERICA
    Date Cleared
    2003-08-20

    (205 days)

    Product Code
    MLY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRYONIC MEDICAL NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRYOTRON 2 ® Cryotherapy Device is for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
    Device Description
    The CRYOTRON 2 ® Cryotherapy Device delivers a topical spray of compressed medical-grade carbon dioxide. The patented technology of the CRYOTRON 2 ® Cryotherapy Device uses the natural expansion of liquid CO₂ to create a cold spray of micro- crystals delivered under pressure. Using a gradual sweeping motion, the user applies the spray to the treatment site for 30-60 seconds at a distance of 3-5 inches. Rapid cooling (thermal shock) occurs when the spray sublimates (passes directly from solid (ice) phase to gas phase) as it contacts the skin. The CRYOTRON 2 ® Cryotherapy Device consists of four components that are housed in a mobile cart: A pistol-grip hand-piece that delivers the carbon dioxide spray. An electronic console/control panel that provides operational information to the user. A rechargeable battery. A cylinder of compressed medical-grade carbon dioxide gas (sold separately). An infrared temperature measurement system continuously monitors the temperature of the skin surface. The skin surface temperature is displayed on the electronic console, and a red LED on the pistol-grip hand-piece flashes when the skin surface temperature falls to 4°C. An optional laser pointer within the pistol-grip hand-piece provides a visual indication of the zone where the skin temperature is measured.
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