510(k) K243236

WHOOP ECG (electrocardiogram) Feature (1.0) by Whoop., Inc. — Product Code QDA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 4, 2025
Date Received: October 10, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Electrocardiograph Software For Over-The-Counter Use
Device Class: Class II
Regulation Number: 870.2345
Review Panel: CV
Submission Type

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.

Other clearances for product code QDA

K240795 — Withings ECG App (June 15, 2025)
K240909 — Samsung ECG App v 1.3 (ECG) (August 2, 2024)
K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (May 2, 2023)
K221774 — Garmin ECG App (January 12, 2023)
K201525 — ECG App (October 8, 2020)
K200948 — Fitbit ECG App (September 11, 2020)
K201168 — ECG Monitor App (August 4, 2020)
DEN180044 — ECG App (September 11, 2018)