FDA 510(k) · Whoop
K243236: WHOOP ECG (electrocardiogram) Feature (1.0) (Whoop., Inc.)
Whoop., Inc. received FDA 510(k) K243236 for WHOOP ECG (electrocardiogram) Feature (1.0), with a decision date of Apr 4, 2025 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K243236 |
|---|---|
| Pathway | 510(k) |
| Applicant | Whoop., Inc. |
| Device name | WHOOP ECG (electrocardiogram) Feature (1.0) |
| Product code | QDA: Electrocardiograph Software For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2345 |
| Device class | Class 2 |
| Date received | Oct 10, 2024 |
| Decision date | Apr 4, 2025 |
| 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 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.
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.
- K201525 ECG App (Apple)
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 QDA is "Electrocardiograph Software For Over-The-Counter Use", class 2, 21 CFR 870.2345. FDA's definition: "An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis."
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.