YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

The YUWELL® Infrared Ear Thermometer (YHT100 and YHT107) is a handheld, battery-powered device that measures human body temperature non-contact using infrared energy from the tympanic membrane. It provides readings in under 2 seconds and is suitable for all ages except preterm or small-for-gestational-age babies, intended for professional and home use but not emergency situations. The YHT107 variant includes Bluetooth connectivity for wireless data transmission.

Both the subject device and predicate (Braun Thermoscan PRO 6000) are infrared ear thermometers with identical product code (FLL), regulation (880.2910), measurement principle, non-contact operation, and similar accuracy (±0.2–0.3°C). Minor differences include response time (subject <12 sec vs predicate 2–3 sec), auto power-off duration (60 sec vs 10 sec), and a narrower patient population (subject excludes preterm/SGA babies). Materials, display resolution, and operating/storage environments are essentially equivalent.

ISO 80601-2-56:2017+A1:2018 (clinical thermometer safety and performance), ASTM E1965-98(2016) (infrared thermometer specification), ASTM E1104-98 (probe covers), IEC 60601-1:2015+A2:2020 (electrical safety), IEC 60601-1-2:2014 (EMC), IEC 60601-1-11:2015 (home healthcare), ISO 10993-1/5/10/23 (biocompatibility), IEC 62304:2006+A1:2015 (software lifecycle).

The subject device shares the same intended use (intermittent ear temperature measurement), measurement technology (infrared), and regulatory classification as the predicate. Performance testing—including a 154-subject clinical study across infants, children, and adults—demonstrated equivalent accuracy and repeatability meeting ISO and ASTM standards. The exclusion of preterm/SGA babies represents a narrower, not broader, patient population and does not introduce new safety concerns. Differences in response time and auto power-off are minor operational features with no impact on measurement accuracy or safety, and all non-clinical testing (EMC, biocompatibility, software, wireless, cybersecurity, reprocessing) passed acceptance criteria, confirming the device is as safe and effective as the predicate.