WHOOP ECG (electrocardiogram) Feature (1.0)— 510(k) K243236

Name: FDA 510(k) clearance K243236
Creator: U.S. Food and Drug Administration
Published: 2025-04-04

Substantially Equivalent

Whoop., Inc.

FDA 510(k) clearance K243236 for WHOOP ECG (electrocardiogram) Feature (1.0), Substantially Equivalent on 2025-04-04. Applicant: Whoop., Inc.. Device class: 2.

Clearance details

Applicant: Whoop., Inc.
Product code: Code QDA
Device class: Class 2
Regulation: 21 CFR 870.2345
Advisory panel: Cardiovascular
Date received: 2024-10-10
Decision date: 2025-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QDA

view all

K240795 — Withings ECG App2025-06-15
K240909 — Samsung ECG App v 1.3 (ECG)2024-08-02
K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification2023-05-02
K221774 — Garmin ECG App2023-01-12
K201525 — ECG App2020-10-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.