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510(k) Data Aggregation

    K Number
    K243513
    Device Name
    DCM (PW-DCM)
    Manufacturer
    PneumoWave, Ltd
    Date Cleared
    2025-04-16

    (155 days)

    Product Code
    LEL
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    PneumoWave, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DCM is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. DCM can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. DCM is indicated for monitoring of adult patients only.
    Device Description
    DCM is a wrist-worn wearable device intended to continuously record high resolution digital acceleration data associated with a patient's physical movement. In practice, a healthcare professional or researcher can prescribe the device to collect physiological data from patients during sleep and in applications where quantifiable analysis of physical motion is desirable. The device is set up to collect data by the healthcare professional then placed on the subject's wrist. The device is designed to be worn during normal activities and/or during sleep over a period of days to weeks. The patient does not need to interact with the device to control data collection. The data stored on the device can be transmitted to the cloud for storage, and made accessible to healthcare professionals or researchers for further analysis. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis. The DCM system comprises a system of components: - wearable biosensor (PW010) - off the shelf mobile device (PW030) running the DCM mobile app (PW400) - cloud-based data storage and data processing (PW100) (back-end) - investigator dashboard (PW500) accessed through a web browser (front-end)
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