bite away two

The bite away® two is a lightweight, handheld, battery-powered device that delivers mild heat via a heated ceramic disc to treat insect stings and bites. It provides temporary relief of pain and itching from bees, wasps, and mosquitoes through user-controlled heat application lasting either 3 or 5 seconds, with the device automatically stopping after the selected duration.

The bite away® two heats a 6 mm ceramic disc to approximately 51°C using two AAA batteries (3 volts DC) and a MOSFET circuit with a microprocessor. Key differences from the predicate include: smaller heated disc (6 mm vs. 7 mm), lighter weight (32 grams dry vs. 40 grams), lower maximum skin surface temperature (47.1°C vs. 48.6°C), and AAA batteries instead of AA batteries. Both devices use the same treatment duration (3 and 5 seconds), hard plastic housing, LED light, audible signal, and are operator-directed for placement on insect bites.

The device was tested against ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation) for biocompatibility; IEC 60601-1:2005 and amendments for electrical safety; IEC 60601-1-2:2014 and IEC TR 60601-4-2:2016 for electromagnetic compatibility; and IEC 62366-1:2015 and IEC 60601-1-11:2015 for usability and safety.

The bite away® two is substantially equivalent to the bite away® neo predicate device because both deliver mild heat to the skin via a heated ceramic disc for identical indications (temporary relief of insect sting and bite pain/itching). Both are user-controlled, OTC, Class II powered heating pads with the same treatment durations, design principles, and energy transfer mechanism. The minor differences in heated disc size, weight, and battery type do not affect the fundamental intended use or safety profile, and non-clinical testing (biocompatibility, electrical safety, electromagnetic compatibility, and software validation) demonstrates the subject device performs as safely and effectively as the predicate.