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510(k) Data Aggregation

    K Number
    K193665
    Device Name
    Frozen N
    Manufacturer
    Yozma BmTech Co., Ltd.
    Date Cleared
    2020-05-28

    (149 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    Yozma BmTech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FROZEN N, cryotherapy device using liquid nitrogen vapor, 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 FROZEN N is a local cryotherapy device used for cooling down tissues by means of nitrogen vapors. Liquid nitrogen, whose boiling point is -196°C, inside the vessel changes into the gas form by heating from a rod-shaped immersion heater operated by AC power. The appearing difference in pressure between atmospheric pressure and the vessel provokes the flow of nitrogen vapors from the vessel to the hose finished with a nozzle mounted on handpiece. The nozzle discharge volume of nitrogen vapors is controlled in 5 levels by the operation time of heater. As the amount of nitrogen decreases, the device is off automatically when the temperature of the heater reaches 60°C where sensed via bimetallic thermometer embedded in heater module. The structural design of device is the movable cart equipped with a weighing system to check the amount of nitrogen in the vessel. Rapid cooling (thermal shock) in the temperature range of 2~4 ℃ occurs within 30-45 seconds when the spray sublimates as it contacts the skin. The device is controlled via touch screen keys of LCD where displays the timer, measured temperature, operating level and remains of nitrogen. Also, the touch key controls the aiming beams mounted on the nozzle side of handpiece that helps the user keeping a proper distance while the two laser beams meet each other. The LED on the hand-piece flickers when the measured drops below 5℃ and the device automatically shuts down when the measured temperature stays -1 ℃ or below for 1 second.
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