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The WHOOP ECG Feature is a software-only mobile medical application intended for use with the WHOOP Strap to create, record, store, transfer, and display a single-channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The WHOOP ECG Feature determines the presence of atrial fibrillation (AFib), normal sinus rhythm, low heart rate (≤ 50 beats per minute [bpm]), and high heart rate (≥ 100 bpm) on a classifiable waveform. The WHOOP ECG Feature is not recommended for users with other known arrhythmias. The WHOOP ECG Feature is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Feature are intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without the consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The WHOOP ECG Feature is intended for use by adults 22 years of age and older.

The WHOOP ECG Feature is a software-only medical mobile application integrated into the consumer (non-device) WHOOP System. It consists of three medical device modules: ECG Strap Module, ECG Phone Module, and ECG Cloud Module. The feature is designed to create, record, store, transfer, and display a single-channel electrocardiogram (ECG), qualitatively similar to a Lead I ECG. It analyzes ECG recordings collected via the ECG electrodes on the WHOOP Strap. The ECG Strap Module firmware is integrated within the WHOOP Strap's firmware. The ECG Strap Module firmware contains the FDA-cleared B-Secur HeartKey Software Library (K200884) which is used to provide classification for a 30-second ECG spot check recording into corresponding WHOOP ECG Feature outputs: Normal Sinus Rhythm; AFib; Low Heart Rate; High Heart Rate; Inconclusive; and Unsuccessful Reading. Users must opt in and complete onboarding through the ECG Phone Module within the WHOOP Mobile Application before accessing the ECG Feature. The ECG Cloud Module processes requests for ECG report generation. Users can download ECG reports in PDF format to their mobile device or share them via applications such as email or messaging. The WHOOP ECG Feature is not intended to replace traditional diagnostic or treatment methods.