c-med0 alpha

The c-med0 alpha is a non-invasive wearable in-ear medical device that measures body temperature, blood oxygen saturation (SpO2), and pulse rate in adults. It connects via Bluetooth to a mobile app for spot-checking and manual data collection in hospitals, medical facilities, and home healthcare settings during non-motion conditions.

The device is a small wearable earbud (55.2×58.6×10.0 mm, 9g) using reflectance pulse oximetry and non-contact infrared technology for temperature measurement. It measures SpO2 (±3% accuracy, 70–100%), pulse rate (40–220 bpm, ±2 bpm), and temperature (34–43°C, ±0.2–0.3°C). Unlike predicate devices, it transmits data wirelessly via Bluetooth rather than wired USB, and can be worn continuously as a wearable.

ISO 80601-2-61 (pulse oximetry), ISO 80601-2-56 and ASTM E1965-98 (infrared thermometry), IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 (electrical safety and EMC), IEC 62304 and IEC 81001-5-1 (software validation and cybersecurity), and ISO 10993 standards (biocompatibility). Clinical studies validated SpO2 and temperature measurement accuracy against blood gas analysis and esophageal temperature.

The c-med0 alpha is substantially equivalent to the MedWand Device (K212975) because it measures the same vital signs (SpO2, pulse rate, temperature) using the same scientific principles (photoelectric pulse oximetry and non-contact infrared thermometry), achieves comparable accuracy, and is indicated for adult spot-checking in similar environments. Differences in form factor (wearable earbud vs. handheld), connectivity (Bluetooth vs. USB), and measuring site (ear vs. body surface) do not raise new safety or effectiveness concerns.