Zanis TempBuddy

About TempBuddy TempBuddy is a connected temperature-monitoring solution designed to make checking and tracking body temperature simple, fast, and convenient. The TempBuddy app works together with the TempBuddy ZTP-800 non-contact infrared thermometer, which connects directly to a compatible USB-C smartphone. The thermometer is battery-free and uses the connected phone for power, display, and interaction. Measurements are presented directly in the TempBuddy app for an easy, streamlined experience. With TempBuddy, users can measure body temperature, view readings in Celsius or Fahrenheit, track measurement history, maintain temperature records, and export recorded information when needed. The system also includes an Object Mode for measuring the surface temperature of inanimate objects. TempBuddy is designed for home temperature monitoring for adults, children, and infants under adult supervision, helping families keep temperature information organized and easier to follow over time. Medical Disclaimer TempBuddy is intended to assist with measuring and tracking body temperature and is not a substitute for professional medical advice, diagnosis, or treatment. Temperature readings should be considered together with symptoms, medical history, age, and overall condition. Always consult a qualified healthcare professional in addition to using TempBuddy and before making medical decisions. If symptoms are severe, worsening, or you believe there may be a medical emergency, seek appropriate medical attention immediately. Regulatory Jurisdiction The TempBuddy ZTP-800 medical hardware is marketed in the United States as a Class II Clinical Electronic Thermometer under FDA Product Code SDV and Regulation Number 880.2910. This device category is exempt from 510(k) premarket notification requirements, and the applicable FDA Establishment Registration and Device Listing requirements have been completed. The TempBuddy application may be available for download in countries and regions outside the United States. Availability of the application in another country or region does not represent or imply regulatory clearance, approval, registration, or authorization of the TempBuddy medical hardware in that jurisdiction. The regulatory status described above applies to the United States. Use of TempBuddy medical hardware in other jurisdictions should comply with applicable local medical-device laws and regulatory requirements.