REMI Remote EEG Monitoring System

The REMI Remote EEG Monitoring System is a wearable, single-channel EEG monitoring device consisting of disposable sensors, a mobile app (REMI Mobile), and cloud storage (REMI Cloud). It amplifies and wirelessly transmits brain electrical activity from a patient's scalp for up to 30 days in healthcare and ambulatory settings. The system displays EEG data to medical professionals and does not make diagnostic conclusions but serves as a physiological signal monitor for patients aged 1+ years.

The subject device is identical to its predicate in nearly all technological attributes: both use 2 passive gold electrodes with conductive hydrogel in a single-use sticker, acquire up to 10 channels via the 10/20 montage system, employ proprietary Bluetooth for sensor-to-app communication and secured WiFi/cellular for app-to-cloud transfer, and process data into standard EEG formats. The key difference is an upgraded hydrocolloid REMI Sticker (versus the predicate's standard hydrogel sticker) to support pediatric patients ages 1–<6 years, with biocompatibility verified for long-term contact versus the predicate's <30-day testing.

Testing conducted to IEC 60601-1:2005 (medical electrical equipment general safety), IEC 60601-1-2:2015 (electromagnetic compatibility), IEC 60601-2-26:2015 (electroencephalograph particular requirements), and IEC 60601-1-11:2015 (home healthcare environment). Biocompatibility testing per ISO 10993-1 with specific tests per ISO 10993-5, ISO 10993-10, and ISO 10993-23. Wireless technology validated per FDA guidance on Radio Frequency Wireless Technology in Medical Devices.

The subject device shares identical intended use, indications, fundamental technology, and component design with the predicate K230933, including the same sensor architecture, wireless transmission method, and cloud processing. The sole technological difference—introduction of a new hydrocolloid sticker for pediatric use ages 1–<6—is supported by: (1) additional biocompatibility testing for long-term skin contact, (2) clinical data from 13 pediatric patients ages 1–<6 years showing safe sensor wear and valid EEG recordings including seizure capture, and (3) unchanged electrical and functional performance metrics. This expansion of the cleared pediatric age range with validated biocompatibility data does not create new risks or performance concerns relative to the predicate.