FDA 510(k) · Mega Electronics
K143032: eMotion Faros ECG Mobile (Mega Electronics , Ltd.)
Mega Electronics , Ltd. received FDA 510(k) K143032 for eMotion Faros ECG Mobile, with a decision date of Mar 29, 2015 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K143032 |
|---|---|
| Pathway | 510(k) |
| Applicant | Mega Electronics , Ltd. |
| Device name | eMotion Faros ECG Mobile |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Oct 22, 2014 |
| Decision date | Mar 29, 2015 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K131699 EMOTION ECG MOBILE (Mega Electronics)
Later records that cite K143032
- K161431 SimplECG (Nanowear, Nov 30, 2016, DXH)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXH is "Transmitters And Receivers, Electrocardiograph, Telephone", class 2, 21 CFR 870.2920.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.