# K143032: eMotion Faros ECG Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Mega Electronics, Ltd.
- Decided: Mar 29, 2015 after 158 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K963725 (1997). 16 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131699: Emotion Ecg Mobile, Mega Electronics, Ltd. (2013) Summary page 4.

## Most influential descendants
- K161431: SimplECG (2016), 5 descendants of its own
- K201669: SimpleSENSE (2020), 3 descendants of its own
- K212160: SimpleSENSE Platform (2021), 1 descendant of its own
- K243981: Hexoskin Medical System (7100-00016) (2025), 0 descendants of its own
- K232053: SimpleSense-BP, SimpleSense-BP Software Application (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K143032
Methodology: https://510kreport.com/methodology