Cleared Traditional

K143032 - eMotion Faros ECG Mobile

K143032 is an FDA 510(k) clearance for eMotion Faros ECG Mobile, manufactured by Mega Electronics , Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K143032 · Mega Electronics , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
158d
Days
Class 2
Risk

K143032 is an FDA 510(k) clearance for the eMotion Faros ECG Mobile. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Mega Electronics , Ltd. (Kuopio, FI). The FDA issued a Cleared decision on March 29, 2015 after a review of 158 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Mega Electronics , Ltd. devices

FDA 510(k) Submission Details - K143032

510(k) Number K143032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2014
Decision Date March 29, 2015
Days to Decision 158 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 125d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 174
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K143032.
Prizma
K170181 · G-Medical Innovations , Ltd. · Sep 2017
SimplECG
K161431 · Nanowear, Inc. · Nov 2016
Vitaphone Tele ECG Loop Recorder
K151013 · Vitasystems GmbH · Apr 2015
Master Caution Device MCD
K142476 · Healthwatch , Ltd. · Feb 2015
AliveCor Heart Monitor
K142743 · AliveCor, Inc. · Jan 2015
AliveCor Heart Monitor
K142672 · AliveCor, Inc. · Dec 2014