Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K233987
    Device Name
    VERABAND™
    Manufacturer
    Arbor Medical Innovations, LLC
    Date Cleared
    2024-06-17

    (182 days)

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

    Arbor Medical Innovations, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VERABAND™ is a compact, lightweight, body-worn activity monitoring device designed to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep for a limited time interval (up to 30- days). The VERABAND™ can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. VERABAND™ is not intended for diagnostic purposes.
    Device Description
    The VERABANDTM is a compact, wrist-worn battery-operated wearable device intended for collecting a patient's motion data for assessing patient activity. VERABANDTM is intended to acquire and store data while being worn during normal activities and/or during sleep. The device consists of a wearable band with compact housing for battery-powered on-board electronics with an accelerometer. The recorded activity data is timestamped and stored in non- volatile memory for later retrieval. Downloaded VERABANDTM data can be post-processed based on the timestamp and magnitude of acceleration for reporting.
    Ask a Question

    Page 1 of 1