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8.2 Classification U.S
Trade/Proprietary Name:
eMotion Faros ECG Mobile
Regulation Classification:
870.2920
Product Code:
DXH
Class of Device:
Class II
Panel:
Cardiovascular
510(k) Number:
K143032
eMotion Faros ECG Mobile Intended Use in USA
The eMotion Faros ECG sensor is a wearable, portable, 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 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.
Indicated for adult patients who require clinical or non-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.
