FDA 510(k) · Mega Electronics
K131699: EMOTION ECG MOBILE (Mega Electronics , Ltd.)
Mega Electronics , Ltd. received FDA 510(k) K131699 for EMOTION ECG MOBILE, with a decision date of Nov 26, 2013 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K131699 |
|---|---|
| Pathway | 510(k) |
| Applicant | Mega Electronics , Ltd. |
| Device name | EMOTION ECG MOBILE |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Jun 11, 2013 |
| Decision date | Nov 26, 2013 |
| 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
Statement 510(k) Number (if known): _________ Device Name: eMotion ECG Mobile 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 coiledt 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. Prescription Use AND/OR Over-The-Counter Use____ X -(21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Digitally signed by gria~O -5 _P.Fauis _C2_101II.265 'a i:W950
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.
Later records that cite K131699
- K143032 eMotion Faros ECG Mobile (Mega Electronics, Mar 29, 2015, 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.