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510(k) Data Aggregation

    K Number
    K220514
    Device Name
    bite away neo
    Manufacturer
    MibeTec, GmbH
    Date Cleared
    2022-06-23

    (121 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    MibeTec, GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bite away® neo is indicated for use to provide temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes.
    Device Description
    The bite away® neo device is a light weight, portable, hand-held, battery powered, user- operated device that produces mild heat for direct contact with the affected areas of the skin. The heat is initiated by the user through the activation of the unit by depressing a non-locking button. The device is provided with two (2) side-by-side buttons. The user has the choice of a short 3 second heat treatment or a 5 second heat treatment depending on which button is depressed. The activation of the unit is signified with the illumination of an LED light and an audible chirp through the use of an electronic buzzer. An audible alarm is activated when there is a user error. The device is not connected to the user as the user is in complete control of the heat treatment and as such, self-delivers the heat treatment to themselves by contacting the device to their own anatomy / treatment site. The short duration of 3 and 5 seconds of heating the device's heated ceramic plate that contacts the patient further alleviates risk of overheating the skin as the device automatically stops heating the element after 3 or 5 seconds; limiting the maximum amount of heat to be delivered to the site. The bite away® neo device utilizes two AA batteries (1.5 volts each) that power a resistor that heats a 7mm ceramic disc to approximately 50°C when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 seconds of heating). The device consists of a few major components: a hard plastic outer case, a printed circuit board, an activation button. AA batteries, and a heated ceramic plate that contacts the printed circuit board consists of the following components: electro-mechanical NOC buttons, microcontroller with programmed firmware, MOSFET transistor heating element, ceramic pad, resistors, coils, capacitor, thermistor temperature sensor and buzzer. The bite away® neo device is approximately 7 inches long and weighs approximately 40 grams.
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