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510(k) Data Aggregation

    K Number
    K252981

    Validate with FDA (Live)

    Device Name
    EmbraceMini
    Manufacturer
    Empatica S.R.L.
    Date Cleared
    2025-12-22

    (96 days)

    Product Code
    LEL
    Regulation Number
    882.5050
    Type
    Traditional
    Panel
    Neurology
    Age Range
    18 - 65
    Reference & Predicate Devices
    K230457
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EmbraceMini is a wearable device intended to be used by trained healthcare professionals or researchers to remotely monitor limb or body movements in ambulatory individuals in home-healthcare environments and professional healthcare environments.

    The device supports continuous data collection for monitoring the following physiological parameters:

    • Physical movement associated with applications in physiological monitoring
    • Activity associated with movement during sleep

    EmbraceMini can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

    Device Description

    EmbraceMini is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is running. The Care App is a component of the FDA cleared Empatica Health Monitoring Platform

    The data received is analyzed by one of the Care App software modules, EmpaDSP, which computes the user's physiological parameters.

    The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.

    EmbraceMini is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments.

    AI/ML Overview

    N/A

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