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510(k) Data Aggregation

    K Number
    K151784
    Device Name
    ActTrust
    Manufacturer
    CONDOR INSTRUMENTS LTDA. - EPP
    Date Cleared
    2016-05-25

    (329 days)

    Product Code
    LEL
    Regulation Number
    882.5050
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K983533,K132764,K111514
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONDOR INSTRUMENTS LTDA. - EPP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ActTrust is an ultra-compact, lightweight, wrist-worn activity, temperature and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and store data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. The device is intended to monitor limb or body movements during daily living and sleep. ActTrust is indicated for adults of 22 years of age and over.

    Device Description

    ActTrust is a compact, ambulatory, battery-operated data recorder with physical characteristics similar to a small wristwatch. The ActTrust is intended for the acquisition and analysis of the physical activity of the body, peripheral temperature and light exposure during daily living and sleep. The ActTrust uses state of the art miniature electronic technology to measure the data and store these data within the device. The ActTrust require operational software to allow configuration, data download, storage and off-line analysis of activity data by a health care provider. The device is connected directly by means of a standard Universal Serial Bus connection for configuration and download.

    AI/ML Overview

    The ActTrust device is an activity, temperature, and ambient light monitor designed to analyze circadian rhythms, collect sleep parameters, and assess physical movement.

    Here's an analysis of the acceptance criteria and study proving the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Requirement SummaryPass/Fail CriteriaTest Result
    The device shall measure linear acceleration with an accuracy of +/-5% over the full range.The recorded acceleration over the test range shall meet the requirement.PASS
    The device accuracy shall be
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