Is HeartCheck Cardi Beat ECG Monitor with GEMS Mobile FDA cleared?

FDA's records list K181310 for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile from Cardiocomm Solutions, Inc.: 510(k), decision date Feb 22, 2019, decision "Substantially Equivalent". The 510(k) pathway means the device was cleared, not approved.

What product code is K181310?

DXH: Transmitters And Receivers, Electrocardiograph, Telephone, regulated under 21 CFR 870.2920, class 2.

FDA 510(k) · Cardiocomm Solutions

K181310: HeartCheck Cardi Beat ECG Monitor with GEMS Mobile (Cardiocomm Solutions, Inc.)

Cardiocomm Solutions, Inc. received FDA 510(k) K181310 for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile, with a decision date of Feb 22, 2019 (substantially equivalent).

Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))

FDA record for K181310 FDA summary or statement (PDF)

FDA facts

Official fields for K181310
FDA number	K181310
Pathway	510(k)
Applicant	Cardiocomm Solutions, Inc.
Device name	HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
Product code	DXH: Transmitters And Receivers, Electrocardiograph, Telephone
Regulation (21 CFR)	870.2920
Device class	Class 2
Date received	May 17, 2018
Decision date	Feb 22, 2019
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 HeartCheck™ Cardi Beat ECG Monitor device with the GEMS Mobile software is an over-the-counter device to be used by patients 21 years of age or older. It is intended to record, store and transfer single channel Heart Rhythm signals and display Heart Rhythm waveforms. This 1-lead cardiac monitor allows remote users to display and transmit their ECG data to medical professionals via a communication device to a remote server. The HeartCheck™ Cardi Beat ECG Monitor combined with GEMS Mobile software is indicated for users who are concerned about their heart rhythms and may have experienced symptoms that may suggest irregular or abnormal heart rhythms. Symptoms may include: • Skipped beats • Palpitations • Racing heart • Fainting and lightheadedness • Irregular rate • History of any related heart abnormalities The HeartCheck™ Cardi Beat ECG Monitor along with the GEMS Mobile software is not intended to substitute a hospital diagnostic ECG device. Users with an implanted pacemaker or are not recommended to use this device while the implanted device is operational. Users where their pacemaker is operational will not be able to record their ECG under normal sinus rhythm with the pacemaker on.

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.

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.