Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Whoop., Inc.. It received FDA 510(k) clearance on 2025-04-04 under approval 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. It is manufactured by Whoop., Inc.. The 510(k) number is K243236.

When was WHOOP ECG (electrocardiogram) Feature (1.0) approved by the FDA?

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

What company makes WHOOP ECG (electrocardiogram) Feature (1.0)?

WHOOP ECG (electrocardiogram) Feature (1.0) is manufactured by Whoop., Inc..

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 Devices (Code: QDA)

DEN180044ECG AppApple, Inc. K201525ECG AppApple, Inc. K200948Fitbit ECG AppFitbit, Inc. K201168ECG Monitor AppSamsung Electronics Co., Ltd. K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd. K221774Garmin ECG AppGarmin International, 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.

↑