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510(k) Data Aggregation

    K Number
    K172778
    Device Name
    CheckMyHeart Plus
    Date Cleared
    2018-07-05

    (294 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DailyCare Biomedical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CheckMyHeart Plus is intended to record, recall, store and transfer Lead I ECG signals for home health care use. The intended users are adults above 21 years old. This device is not intended to substitute for a hospital diagnostic ECG device. This device is also not intended for recording and transmission of user's ECG signals simultaneously.
    Device Description
    CheckMyHeart Plus is intended to record, recall, store and transfer single lead electrocardiographic monitor for recording and displaying real-time ECG data for home health care use. The intended users are adults above 21 years old who might experience transient symptoms that may suggest cardiac conduction abnormity or by adult users whenever they want to have routine checks. This device is not intended to substitute for a hospital diagnostic ECG device. ECG acquisition and transmission can be voluntarily and mutually activated by the adult users for the purpose of healthcare management and reference for healthcare professionals. This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis. CheckMyHeart Plus is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions for daily health check. It takes ECG signals of users with thumbs press on electrode at CheckMyHeart Plus gently. The device will record user's ECG signal for 300 seconds, and automatically stores signals into the build-in memory.
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