WHOOP ECG (electrocardiogram) Feature (1.0)
Whoop, Inc.The WHOOP ECG (electrocardiogram) Feature is a mobile application software used with the WHOOP Strap wearable device to record and analyze a single-channel ECG signal similar to a Lead I ECG. It helps users detect atrial fibrillation, normal sinus rhythm, and abnormal heart rates by providing informational ECG data and rhythm classification, aiding users and clinicians in heart rhythm monitoring without replacing traditional diagnosis methods.
Intended Use
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. It determines the presence of atrial fibrillation (AFib), normal sinus rhythm, low heart rate (≤ 50 bpm), and high heart rate (≥ 100 bpm) on classifiable waveforms. It is intended for over-the-counter use by adults 22 years and older, providing informational use only and not to replace traditional diagnosis or treatment.
Technology
The device is a software-only medical application integrated into the WHOOP consumer system. It consists of three modules: ECG Strap Module firmware with FDA-cleared HeartKey Software Library for ECG signal processing and rhythm classification; ECG Phone Module for user interaction and onboarding; and ECG Cloud Module for ECG report generation and sharing. It creates, records, stores, transfers and displays single-channel ECG signals collected from the WHOOP Strap electrodes, and classifies 30-second ECG recordings according to rhythm output categories such as AFib, sinus rhythm, and heart rate variations.
Performance
Performance testing included software verification, cybersecurity, database testing, EMC, electrical safety, signal acquisition, human factors validation, and clinical testing. Clinical testing involved approximately 540 subjects comparing WHOOP ECG recordings against cardiologist-interpreted 12-lead ECGs. Results showed 96.2% sensitivity in detecting AFib and 99.4% specificity for sinus rhythm classifications. The device demonstrated acceptable ECG signal quality 99.4% of the time. Usability studies confirmed users can correctly operate the device and interpret outputs. Testing demonstrated equivalence to the predicate Apple ECG App 2.0 without raising new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/10/2024
5 months - 2
FDA Approval
4/4/2025
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