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510(k) Data Aggregation

    K Number
    K143032
    Device Name
    eMotion Faros ECG Mobile
    Manufacturer
    MEGA ELECTRONICS LTD.
    Date Cleared
    2015-03-29

    (158 days)

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

    MEGA ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The eMotion Faros ECG sensor is a wearable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research. The eMotion Faros ECG Mobile is intended for use in clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug-in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. Indicated for adult patients who require clinical ECG monitoring in healthcare facility environment under supervision of a physician or prescript by the supervising physician to supplement data acquisition in home environment. The eMotion Faros ECG Mobile does not provide any automatic analysis or diagnosis.
    Device Description
    The eMotion Faros ECG Mobile is a mobile device. PC and Internet based telemetry solution for the ambulant monitoring of the pluq-in device data of chronic patients via a mobile network. Pluq-in devices can be ECG devices, blood pressure monitors, weighing scales, etc. The device reads data from the plug-in device via a Bluetooth connection. The mobile device sends the data to a server (Health Gateway) over mobile networks using the secured connection. Data can be viewed from the Health Gateway server using the Virtual Clinic interface. Monitoring is performed using PC application that reads data from the server over the internet using the secured connection. ECG data is possible to record on eMotion Faros ECG sensors internal memory. Data from ECG sensors can be reviewed with eMotion EDF Viewer or uploaded via USB connection. Data acquisition is performed using eMotion Faros ECG sensors and applicable plug-in devices. Faros ECG sensors are modified versions of eMotion ECG sensor which the FDA granted clearance on November 26, 2013 (K131699).
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    K Number
    K131699
    Device Name
    EMOTION ECG MOBILE
    Manufacturer
    MEGA ELECTRONICS LTD.
    Date Cleared
    2013-11-26

    (168 days)

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

    MEGA ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The eMotion ECG sensor is a wearable, portable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research. The eMotion ECG Mobile is intended for use in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug-in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The eMotion ECG Mobile does not provide any automatic analysis or diagnosis.
    Device Description
    The eMotion ECG Mobile is a mobile device, PC and Internet based telemetry solution for the ambulant monitoring of the plug-in device data of chronic patients via a mobile network. Plug-in devices can be ECG devices, blood pressure monitors, weighing scales, etc. The device reads data from the plug-in device via a Bluetooth connection. The application in the mobile device sends the data to a server (Health Gateway) over mobile networks using the secured connection. Data can be viewed from the Health Gateway server using the Web Monitor. Monitoring is performed using PC application that reads data from the server over the internet using the secured connection.
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    K Number
    K993411
    Device Name
    FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
    Manufacturer
    MEGA ELECTRONICS LTD.
    Date Cleared
    2000-01-10

    (90 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEGA ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemiScan™ devices are intended as an aid for exercising and training pelvic floor muscle activation, control and optionally coordination with the abdominal muscle group. It is indicated in the treatment of stress and mixed female urinary incontinence under the supervision of a physician. The FemiScan™ Clinic System is used in the physician office, clinic, or hospital environment. The FemiScan™ Personal System is used to supplement these exercises in the home environment.
    Device Description
    The FemiScan™ Clinic and Personal Systems consist of a palmsized measuring unit with a computer-based user interface and data acquisition system for data collection and data transfer. The devices feature a 2 channel EMG vaginal probe.
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    K Number
    K963202
    Device Name
    MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
    Manufacturer
    MEGA ELECTRONICS LTD.
    Date Cleared
    1997-05-19

    (277 days)

    Product Code
    HCC, 84H
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEGA ELECTRONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Model ME3000P Professional Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle re-education and relaxation training.
    Device Description
    The ME3000P is a portable, battery powered EMG recorder. The ME3000P is an electronic device used to gather and display electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training. The signals are received via conductive adhesive skin electrodes and may be displayed or stored for display at a later time. Signals may be gathered from two or more channels. Data downloading or transfer is via a standard fiber optic cable to a PC. The product does not relay any electrical or stimulatory signals to the body. It is only a signal recorder with display capabilities.
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