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510(k) K243236

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

K243236 is an FDA 510(k) premarket notification submitted by Whoop., Inc. for the device "WHOOP ECG (electrocardiogram) Feature (1.0)". The FDA issued a decision of Substantially Equivalent on April 4, 2025. The device falls under product code QDA (Electrocardiograph Software For Over-The-Counter Use), a Class II device regulated under 21 CFR 870.2345.

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)

FDA data resources