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FDA 510(k)

Withings ECG App

K-Number: K240795 · 2025-06-15

ApplicantWithings
Decision Date2025-06-15
Product CodeQDA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Withings ECG App is the device name listed in this FDA 510(k) record. The listed applicant is Withings. It received FDA 510(k) clearance on 2025-06-15 under 510(k) number K240795. 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 Withings ECG App?

Withings ECG App is a medical device that received FDA 510(k) clearance on 2025-06-15. The listed applicant is Withings. The 510(k) number is K240795.

When did Withings ECG App receive FDA 510(k) clearance?

Withings ECG App received FDA 510(k) clearance on 2025-06-15, under 510(k) number K240795.

Who is the listed applicant for Withings ECG App?

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

What is the FDA product code for Withings ECG App?

The FDA product code for Withings ECG App 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.

NCT06637878SCT02 Clinical Accuracy ValidationCOMPLETEDNCT07595016Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-EclampsiaRECRUITINGNCT07631715Withings Hypertension Notification Retrospective StudyACTIVE_NOT_RECRUITINGNCT07654491Withings HFRN Retrospective StudyNOT_YET_RECRUITING

Other records listing Withings as applicant

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.

K252474Withings BeamO (SCT02)K231667Withings Sleep RxK230812Withings Scan Monitor 2.0K201456Scan MonitorK160544Withings Thermo (Model SCT01)

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.

K243236WHOOP ECG (electrocardiogram) Feature (1.0)Whoop., Inc.K240909Samsung 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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