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FDA 510(k)

WHOOP ECG (electrocardiogram) Feature (1.0)

K-Number: K243236 · 2025-04-04

ApplicantWhoop., Inc.
Decision Date2025-04-04
Product CodeQDA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WHOOP ECG (electrocardiogram) Feature (1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Whoop., Inc.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K243236. The device is classified under product code QDA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WHOOP ECG (electrocardiogram) Feature (1.0)?

WHOOP ECG (electrocardiogram) Feature (1.0) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Whoop., Inc.. The 510(k) number is K243236.

When did WHOOP ECG (electrocardiogram) Feature (1.0) receive FDA 510(k) clearance?

WHOOP ECG (electrocardiogram) Feature (1.0) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K243236.

Who is the listed applicant for WHOOP ECG (electrocardiogram) Feature (1.0)?

The FDA 510(k) record lists Whoop., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WHOOP ECG (electrocardiogram) Feature (1.0)?

The FDA product code for WHOOP ECG (electrocardiogram) Feature (1.0) is QDA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06425939Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise PerformanceCOMPLETED

Related Devices (Code: QDA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240795Withings ECG AppWithingsK240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.K221774Garmin ECG AppGarmin International, Inc.K201525ECG AppApple, Inc.K200948Fitbit ECG AppFitbit, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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