The Frontier X Plus™ by Fourth Frontier® is a wearable ambulatory electrocardiogram (EKG or ECG) recorder and display product that consists of a device affixed to the chest strap, a companion mobile application, and a web application for analysis of ECG. It is a novel, self-applied continuous ambulatory ECG solution for arrhythmia detection and management.

The Frontier X Plus system also displays ECG waveform and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythms. The device is intended for use by healthcare professionals to monitor patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device is a non-invasive, lightweight, rechargeable battery- operated wireless ambulatory ECG monitor.

Early detection of atrial fibrillation (AFib) is crucial for preventing serious cardiac complications. Timely detection allows for early intervention through medication, lifestyle changes, or medical procedures, improving patient outcomes and preventing long-term health issues. The FDA-cleared Frontier X Plus, a chest strap-based heart monitor,  records and transfers single-channel ECG and provides automated detection of atrial fibrillation and other arrhythmias. Frontier X Plus achieves this with exceptional accuracy, boasting 98.10% sensitivity and 97.88% specificity for AFib detection.

The Frontier X Plus improves patient compliance by offering a lightweight, wearable chest monitor that is comfortable and easy to use. Its real-time data tracking and wireless connectivity provide patients with instant feedback, making them more engaged in their health management. The wearable ECG solution is designed for comfort, encouraging consistent use. Patients can self-apply the device and integrate it effortlessly into their daily routines without disrupting their activities.

The Frontier X Plus  should not be used by individuals under the age of 22 years, pregnant women, or patients with potentially life-threatening arrhythmias requiring hospitalization or real-time/in-patient monitoring. Additionally, it is not suitable for individuals with known skin allergies to the materials listed in the "List of Patient-Contacting Materials."(mentioned in the section 1.4.4 of Frontier X Plus User Manual(PUBFXP001_Rev A0)

No, the device should not be used in combination with external cardiac defibrillators or high-frequency surgical equipment.

Do not use a defibrillator with the Frontier X Plus device, as it may cause damage. Ensure the device is removed from areas where defibrillator electrodes are placed.

No, the Frontier X Plus is not indicated for the detection of cardiac conditions such as ischemia, myocardial infarction, or left ventricular hypertrophy (LVH).

If the app identifies conditions like ventricular flutter, ventricular bigeminy, or ventricular trigeminy as unreadable, consult a physician for further analysis.

No, Frontier X Plus does not guarantee the absence of arrhythmias or other health conditions even if an ECG is labeled as normal. Always consult a physician for any potential health changes.