EmbraceMini

EmbraceMini is a wearable wrist-worn device that continuously collects movement data via accelerometer sensors and transmits it wirelessly to a paired mobile app. It monitors physical movement and sleep activity in ambulatory adults in home and professional healthcare settings, used by trained healthcare professionals or researchers for retrospective remote monitoring of physiological parameters and circadian rhythm analysis.

EmbraceMini uses an accelerometer with MEMS-based integrated circuit technology, 26–208 Hz sampling rate, ±16 g dynamic range, and 0.488 milli-g sensitivity—identical to the predicate. It communicates via Bluetooth Low Energy to a mobile device running the Care App, which shares identical software modules and cloud integration as the predicate. The device has only an LED display versus the predicate's screen, but uses the same rechargeable lithium-ion battery and ISO 10993-1 compliant patient-contacting materials.

ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 62366-1 (usability), IEC 60601-1-6 (medical device usability), IEC 60601-1-11 (home healthcare environments), and FDA Radio Frequency Wireless Technology in Medical Devices Guidance (August 2013).

EmbraceMini is substantially equivalent to the Empatica Health Monitoring Platform (K230457) predicate because both devices are Class II sleep assessment monitors manufactured by Empatica with identical accelerometer technology, wireless communication, battery type, and software computation for activity counts and sleep detection. Although EmbraceMini has a more limited indication (physical movement and sleep activity only versus the predicate's broader physiological parameters), this narrower scope does not raise additional safety or performance concerns, and bench testing confirmed equivalence of activity and sleep outputs.