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510(k) Data Aggregation

    K Number
    K170506
    Device Name
    ECG Check - Universal, ECG Check - Universal Plus
    Manufacturer
    Cardiac Designs, Inc.
    Date Cleared
    2017-10-02

    (223 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cardiac Designs, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECG Check Universal family of devices is intended for self-testing by patients at home. These 1-lead cardiac monitors allow remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server. Specifically, the ECG Check Universal models are indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms: - · Skipped Beats - · Pounding Heart (Palpitations) - · Heart Racing or Irregular Pulse - · Lightheadedness or Faintness - · History of Arrhythmias
    Device Description
    The new ECG CHECK – UNIVERSAL model devices are personal 1 lead ECG Event Monitors specifically designed to operate over the cellular network with iPhone & Android cellular phone handsets. The new ECG CHECK – UNIVERSAL model devices include two models. The ECG CHECK -UNIVERSAL (Model ECG01-U) and the ECG CHECK - UNIVERSAL PLUS (Model ECG01-UPLUS). Both models are designed to capture a user's ECG data and transmit the data via Bluetooth to a cellular device, which will ultimately transmit the ECG data over the cellular network to the ECG Check web center. The difference between the two models is that the new ECG CHECK -UNIVERSAL PLUS allows for the storage of recordings on the device and includes a button for the added capability of transmitting these ECG data transtelephonically using landlines to the ECG Check web center. The button also provides indication of the number of saved ECG recordings as well as the ability to delete saved recordings. Both new ECG CHECK - UNIVERSAL model devices will record a preselected amount of user ECG activity, as directed by the user. Typical configuration is to record 30 seconds of ECG per event.
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