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510(k) Data Aggregation

    K Number
    K062894
    Device Name
    INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0
    Manufacturer
    DAILYCARE BIOMEDICAL INC
    Date Cleared
    2007-02-08

    (134 days)

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

    DAILYCARE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor for recording and displaying real-time ECG data for home health care use. This device is intended for self-testing by adult users who might experience transient symptoms that may suggest cardiac conduction abnormity or by adult users whenever they want to have routine checks. 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. The user is normally not required to apply electrode on body. Two electrodes integrated within the device are provided. The user has to press his/her thumbs on the electrodes in order to record the ECG signal. The users may also record the signals optionally through auxiliary external electrode provided separately if thumb pressing is not convenient for reason. The recorded data can be downloaded to Personal Computer via USB interface port.
    Device Description
    The InstantCheck RTD-ECG monitor is a new model of handheld ECG monitors series of DailyCare BioMedical Inc. InstantCheck RTD-ECG is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions and displays the data in a clear and precise waveform for daily health check. It takes ECG signals of users by thumbs pressing gently on electrodes which are integrated on the device. InstantCheck RTD-ECG can record real-time display the user's ECG data for about 30 seconds, and automatically store the last 15 seconds signals into the build-in memory. While three parameters were measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, will be displayed on LCD display of the device. User may also record ECG data optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The data stored in the memory can be transferred to Personal Computer via USB. With friendly GUI software provided separately, data stored in InstantCheck RTD-ECG can be printed for analysis, and for long-term tracking. InstantCheck RTD-ECG is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually. InstantCheck RTD-ECG is not intended for use as a substitution of precise diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device.
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    K Number
    K052303
    Device Name
    READMYHEART, MODEL RMH2.0
    Manufacturer
    DAILYCARE BIOMEDICAL INC
    Date Cleared
    2005-12-16

    (114 days)

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

    DAILYCARE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ReadMyHeart OTC version is intended to record, store and transfer Lead I ECG signals, and display three ECG parameters for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device. The ReadMyHeart OTC version has simple software user interface without ECG trace viewing function.
    Device Description
    ReadMyHeart is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions for daily health check. It takes signals of users with the device and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate, ST segment and RRS interval of cardiac ECG signal, displays on LCD of the device. User may also record ECG signals optionally through auxiliary external electrode which will be provided separately. ReadMyHeart is powered by battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.
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    K Number
    K050620
    Device Name
    READMYHEART, MODEL RMH3.0
    Manufacturer
    DAILYCARE BIOMEDICAL INC
    Date Cleared
    2005-07-14

    (126 days)

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

    DAILYCARE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for home use by users who might have transient symptoms that may suggest cardiac conduction abnormity or by users who want to monitor the cardiac function for HOME HEALTH CARE from Lead I ECG signal. ECG acquisition and transmission is voluntary and mutually activated by the user. The intended users are adults above 20 years old. This device is not intended for use as precisely diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. 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. The device detects the appearance of irregular heart beat (IHB) during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. Users with implanted pacemaker are not recommended to use this device.
    Device Description
    ReadMyHeart 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 ReadMyHeart gently. The device will record user's ECG signal for 30 seconds, and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, displays on LCD of the device. The device also detects the appearance of irregular heart beat (IHB) during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis when recording the signal for 180 seconds. The HRV is not intended to produce any interpretation of those measurements or any kind of diagnosis. User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The data stored in the memory can be transferred to Personal Computer via USB. With friendly GUI software provided separately, data stored in ReadMyHeart can be printed for analysis, and for long-term tracking. ReadMyHeart is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually. Furthermore, ReadMyHeart (Model RMH3.0) is modified and has generally the same design from DailyCare BioMedical Inc.'s prior device – ReadMyHeart (RMH2.0, K042814).
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    K Number
    K042814
    Device Name
    READMYHEART
    Manufacturer
    DAILYCARE BIOMEDICAL INC
    Date Cleared
    2005-01-06

    (86 days)

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

    DAILYCARE BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a personal single lead Electrocardiograph monitor. The device is intended for self-testing by patients by recording 15 seconds of the first standard lead I of Electrocardiogram. The recording is activated by the patient when symptoms are experienced or whenever desired as routine recordings to be analyzed by a trained physician. The intended user are Users who are above 20 years old. The user is normally not required to apply electrode on the body. Two electrodes integrated within the device are provided. The user has to press his thumbs on the two electrodes in order record the ECG signal. The User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The recorded data can be downloaded to Personal Computer via USB interface port. This device is not intended for use as precisely diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device.
    Device Description
    ReadMyHeart 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 user/patient with thumbs press on electrode at ReadMyHeart gently. The device will record user's ECG signal for 30 seconds, and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, displays on LCD of the device. User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The data stored in the memory can be transferred to Personal Computer via USB. With friendly GUI software provided separately, data stored in ReadMyHeart can be printed for analysis, and for long-term tracking. ReadMyHeart is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.
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