# K243236: WHOOP ECG (electrocardiogram) Feature (1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Whoop., Inc.
- Decided: Apr 4, 2025 after 176 days
- Product code: QDA (Electrocardiograph Software For Over-The-Counter Use)
- Device class: 2
- Regulation: 21 CFR 870.2345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN180044 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201525: ECG App, Apple, Inc. (2020) Summary page 5.

## Indications for 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. 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.

Source page: https://510kreport.com/device/K243236
Methodology: https://510kreport.com/methodology