Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K171244
    Device Name
    Physiotrace
    Manufacturer
    NimbleHeart, Inc.
    Date Cleared
    2017-08-23

    (117 days)

    Product Code
    DRX, MHX, MWI
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    NimbleHeart, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Physiotrace™Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotrace™ Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotrace™ Smart is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional. The Physiotrace™ Smart is not indicated for use on critical care patients. The Physiotrace™ Smart is not indicated for diagnosis of cardiac conditions.
    Device Description
    The Physiotrace™ Smart has a wearable design that can be wrapped and fastened around the torso. The device uses dry ECG electrodes and embeds an ECG acquisition unit with a Bluetooth Low Energy transmitter. A mobile application controls the data acquisition, displays the status of the device, heart rate and optionally the ECG waveform during a recording session. The mobile App also stores the ECG and the exercise session information and relays it to a cloud server for permanent storage and review by healthcare staff. The Physiotrace™ Smart is designed to be used without electrolytic gels and without adhesives that necessitate skin preparation.
    Ask a Question

    Page 1 of 1