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510(k) Data Aggregation

    K Number
    K221234
    Device Name
    TargetCool
    Manufacturer
    RecensMedical Inc.
    Date Cleared
    2022-07-22

    (84 days)

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

    RecensMedical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TargetCool™ 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
    TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device Cooling-Nozzle, a guard, a filter, and a cartridge. In Cooling mode, the main device produces controlled cooling based on thermoelectric cooling, which controls the temperature (2-4°C) of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1 ℃ and lasts for more than 1 second, the status light blinks in blue with a beep sound.
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    K Number
    K220674
    Device Name
    TargetCool
    Manufacturer
    RecensMedical Inc.
    Date Cleared
    2022-03-31

    (23 days)

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

    RecensMedical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TargetCool™ 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
    TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device Cooling-Nozzle, a guard, a filter, and a cartridge, In Cooling mode, the main device produces controlled cooling based on thermoelectric cooling. which controls the temperature (2-4℃) of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -19C and lasts for more than 1 second, the status light blinks in blue with a beep sound. The principle of pain relief through skin cooling is as follows: As the skin cools by spraying the cryogen onto the skin, the nerve conduction velocity (NCV) of the skin decreases, increasing the pain threshold (PTH) and pain tolerance (PT). Through this mechanism, pain in the skin is relieved. The advances represented by TargetCool™ lie in the fact that the device executes this process in a precise, controlled, and rapid way.
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