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510(k) Data Aggregation
K Number
K143032Device Name
eMotion Faros ECG Mobile
Manufacturer
MEGA ELECTRONICS LTD.
Date Cleared
2015-03-29
(158 days)
Product Code
DXH
Regulation Number
870.2920Why 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
K131699Device Name
EMOTION ECG MOBILE
Manufacturer
MEGA ELECTRONICS LTD.
Date Cleared
2013-11-26
(168 days)
Product Code
DXH
Regulation Number
870.2920Why 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
K993411Device 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
884.1425Why 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
K963202Device Name
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
Manufacturer
MEGA ELECTRONICS LTD.
Date Cleared
1997-05-19
(277 days)
Product Code
HCC, 84H
Regulation Number
882.5050Why 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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