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510(k) Data Aggregation

    K Number
    K182392
    Device Name
    Frozen C
    Manufacturer
    B.M. Tech. Worldwide Co., Ltd.
    Date Cleared
    2018-10-30

    (56 days)

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

    B.M. Tech. Worldwide Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FROZEN C, hyperbaric CO2 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 FROZEN C Cryotherapy Device uses a compressed medical-grade liquid carbon dioxide as cryogen to deliver a topical refrigerant. Using the natural expansion of liquid CO2, it creates a cold spray of microcrystals delivered under pressure. The FROZEN C Cryotherapy Device consists of a cylindrical grip hand-piece, touchscreen console for operation and display, infrared temperature sensor, and a cylinder of compressed medical-grade carbon dioxide gas (sold separately). The touchscreen provides continuous monitoring by displaying the measured skin temperature, treatment duration by timer set, and residual volume of CO2 gas. The user applies the CO2 spray to the treatment site for 30-60 seconds at a distance of 7cm through a gradual circular motion of handpiece. Rapid cooling (thermal shock) occurs when the spray sublimates (passes directly from solid (ice) phase to gas phase) as it contacts the skin. The contact point where the two laser pointers meet is designed to guide the appropriate distance from the skin surface where the skin temperature is measured. If the laser pointer is not required by use environment, it is easy to deactivate by using on/off button in the touch screen. The LED on the hand-piece flickers when the measured temperature drops below 5℃ and the device automatically shut down when the measured temperature stays below 0℃ for 1 seconds.
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