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510(k) Data Aggregation

    K Number
    K250047
    Device Name
    bite away two
    Manufacturer
    Date Cleared
    2025-09-12

    (245 days)

    Product Code
    Regulation Number
    890.5740
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The bite away® two is indicated for use to provide temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes.

    Device Description

    The mibeTec bite away® two device is a light weight, portable, handheld, 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 error message 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. As in any user-controlled heat therapy, the user determines the tolerance to such delivered heat and applies and removes the heat treatment per their own tolerance; thereby virtually alleviating the risks of inadvertent overheating of the skin. The short duration of treatment time of 3 and 5 seconds and the small surface area of the 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 mibeTec bite away® two device utilizes two AAA batteries (1.5 volts each) that power a MOSFET that heats a 7mm ceramic disc to approx. 51C +/- 1% when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 seconds or 5 seconds of heating). The device consists of a few major components: a hard plastic outer case, a printed circuit board, two activation buttons, two AAA batteries, and a heated ceramic plate that contacts the patient.

    AI/ML Overview

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