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Withings ECG App

by Withings

510(k) K240795

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK240795 Date15 Jun 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QDA
Device class
Class II
Regulation
21 CFR Part 870.2345
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Withings ECG App is an electrocardiograph software intended for over-the-counter use, designed to record, analyze, and display single-lead electrocardiogram (ECG) signals. It functions as a software-based medical device that enables users to capture heart rhythm data through a compatible mobile device, providing a tool for cardiovascular monitoring.

The app is supplied as a software application for mobile devices and is intended for use in home or consumer settings. It operates as a single-use digital tool requiring no physical consumables, and its use is subject to software version controls and device compatibility requirements. The device is regulated under FDA 510(k) clearance with product code QDA and is classified as a Class II medical device under regulation number 870.2345.

Similar devices

Other devices filed under FDA product code QDA (Electrocardiograph Software For Over-The-Counter Use).

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