Skip to content

eMotion Faros ECG Mobile

by Mega Electronics, Ltd.

510(k) K143032

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK143032 Date29 Mar 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXH
FDA applicant
Mega Electronics , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The eMotion Faros ECG Mobile is a wearable, portable electrocardiograph recorder and wireless transmitter. It is designed for ECG measurement, heart rate variability data measurement, and patient motion capturing, with the capability to generate event markers using built-in arrhythmia detection algorithms.

This device is authorized under FDA 510K clearance. It is intended for use in monitoring patient ECG data as part of the eMotion Faros series, which includes the 90, 180, and 360 models.

Other devices from Mega Electronics, Ltd.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the eMotion Faros ECG Mobile?

    The device is designed for measuring patient ECG data, monitoring heart rate variability, and capturing patient motion. It also features built-in arrhythmia detection algorithms that can generate event markers during use.

  • Which models are included in the eMotion Faros series?

    The eMotion Faros series includes the 90, 180, and 360 models, all of which are designed for monitoring patient ECG data.

  • What is the regulatory status of this device?

    The eMotion Faros ECG Mobile is authorized under FDA 510K clearance, having been determined to be substantially equivalent to other devices in its class.