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510(k) Data Aggregation

    K Number
    K083535
    Device Name
    HEARTRAK SMART ECAT
    Manufacturer
    UNIVERSAL MEDICAL, INC.
    Date Cleared
    2008-12-15

    (17 days)

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

    UNIVERSAL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Heartrak ECAT is a hand-held, portable, externally applied, cardiac event recorder; electrocardiograph transmitter. Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or auto-triggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center. Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.
    Device Description
    Heartrak Smart ECAT is a cardiac event recorder that is used to continuously scan and capture ECG signals. Patients can use Heartrak Smart ECAT to capture ECG data both before and after they experience a cardiac symptom. Heartrak Smart ECAT can capture and automatically record asymptomatic, infrequent, or illusive arrhythmia events such as Bradycardia, and Atrial Fibrillation. Heartrak Smart ECAT can store up to 30 days of ECG data in its memory. The physician can use a compatible wireless device to set event recording times and autotriggering parameters and then upload them to a patient's monitor. Using wireless technology, Heartrak Smart ECAT, when placed within range (less than 10 meters) of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center. The physician is to instruct the patient on the proper use and care of the Heartrak Smart ECAT monitor. Patients should be told to contact their physician if they have any further questions.
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    K Number
    K071130
    Device Name
    HEARTRAK AF
    Manufacturer
    UNIVERSAL MEDICAL, INC.
    Date Cleared
    2008-05-14

    (387 days)

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

    UNIVERSAL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Heartrak Smart AF is a hand-held, portable, externally applied, cardiac event recorder that is intended for transtelephonic use. Patient calls a receiving center at the hospital or physician's office from the patient's home to play back the recording. Heartrak Smart AF converts electrocardiogram (ECG) signals into audio tones which are transmitted over the telephone lines. Heartrak Smart AF does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AF is not a diagnostic tool and performs no diagnostic functions.
    Device Description
    Heartrak Smart AF is a hand-held, portable, externally applied transtelephonic cardiac event recorder device, which is intended for transtelephonic use.
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    K Number
    K033451
    Device Name
    HEARTRAK SMART AT/HEARTRAK SMART2
    Manufacturer
    UNIVERSAL MEDICAL, INC.
    Date Cleared
    2004-02-05

    (98 days)

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

    UNIVERSAL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used as a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope and syncope events.
    Device Description
    Heartrak Smart AT/ Heartrak Smart ² is a patient-activated transtelephonic ECG loop memory monitor which records cardiac patients' symptoms. The patient calls the receiving center, hospital or physician's office from the patient's home. Heartrak Smart AT/Heartrak Smart² converts signals into audio tones which are transmitted over telephone lines. Heartrak Smart AT/Heartrak Smart" is a hand held, portable, externally applied device which is intended for transtelephonic use. Heartrak Smart AT/Heartrak Smart² does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AT/Heartrak Smart² is not a diagnostic tool and performs no diagnostic functions.
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    K Number
    K980624
    Device Name
    CARDIOSTATION
    Manufacturer
    UNIVERSAL MEDICAL, INC.
    Date Cleared
    1998-05-11

    (82 days)

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

    UNIVERSAL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices. It is intended that the Cardiostation will be used by physicians and cardiac laboratories supervised by physicians.
    Device Description
    Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices.
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    K Number
    K960499
    Device Name
    HEARTRAK XL
    Manufacturer
    UNIVERSAL MEDICAL, INC.
    Date Cleared
    1996-08-06

    (186 days)

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

    UNIVERSAL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954495
    Device Name
    PACETRAK PLUS
    Manufacturer
    UNIVERSAL MEDICAL, INC.
    Date Cleared
    1996-04-22

    (208 days)

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

    UNIVERSAL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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