Identifiers
- 510(k) Number
- K240795 FDA 510(k)
- FDA Product Code
- QDA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2345 FDA 510(k)
- Regulation Number
- 870.2345 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240795 | Class II | Active |
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Manufacturer
- Manufacturer
- Withings
Sources (1)
- FDA 510(k) K240795 24 fields · synced Sep 24, 2026