# K131699: Emotion Ecg Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Mega Electronics, Ltd.
- Decided: Nov 26, 2013 after 168 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: 5 generations back to K963725 (1997). 15 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083535: Heartrak Smart Ecat, Universal Medical, Inc. (2008) Summary page 1.
- K050940: PMP4 Medical Web Center, Card Guard Scientific Survival, Ltd. (2005) Summary page 1.

## Most influential descendants
- K141813: Rhythmstar System (2014), 8 descendants of its own
- K143032: eMotion Faros ECG Mobile (2015), 6 descendants of its own
- K161431: SimplECG (2016), 5 descendants of its own
- K201669: SimpleSENSE (2020), 3 descendants of its own
- K183704: RX-1 Rhythm Express Remote Cardiac Monitoring System (2019), 2 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K131699
Methodology: https://510kreport.com/methodology