AION TempShield™

The AION TempShield™ is a battery-powered wearable thermometer worn on the upper chest for continuous measurement of human body temperature. It wirelessly communicates temperature data to a smartphone or tablet application and is intended for single-use in persons aged 1 year and older in healthcare facilities or home environments.

The device uses a thermistor sensor with ±0.1°C accuracy (25–43°C), Bluetooth LE 4.2 with NFC RFID for power-on and pairing, and a CR2016 lithium coin cell battery providing 90 days of continuous runtime. Compared to the primary predicate (iTempShield), it is identical except for expanded patient age range (1 year vs. 5 years and older), extended battery life (90 days vs. 60 days), and firmware changes supporting battery life extension.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare safety), IEC 60529 (ingress protection), IEC 62366-1 and IEC 60601-1-6 (usability), ISO 80601-2-56 (clinical thermometer performance), ISO 10993-1/5/10/23 (biocompatibility), and FCC Part 15/Part 2 (wireless).

The subject device is substantially equivalent because it shares identical indications for use, placement location (upper chest), classification regulation (21 CFR 880.2910), principle of operation (skin temperature measurement via thermistor), and accuracy (±0.1°C) with the primary predicate iTempShield. The differences—expanded age range to 1 year (supported by clinical data and usability testing with 39 participants ages 1–4), extended battery life (supported by firmware changes and bench testing), and smaller size—do not raise new safety or effectiveness questions, as all testing to consensus standards passed and the device maintains identical core functionality and safety profile.