K240795 is an FDA 510(k) clearance for the Withings ECG App. This device is classified as a Electrocardiograph Software For Over-the-counter Use (Class II - Special Controls, product code QDA).
Submitted by Withings (Issy-Les-Moulineaux, FR). The FDA issued a Cleared decision on June 15, 2025, 450 days after receiving the submission on March 22, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2345. An Electrocardiograph Software Device For Over-the-counter Use Creates, Analyzes, And Displays Electrocardiograph Data, And Can Provide Information For Identifying Cardiac Arrhythmias. This Device Is Not Intended To Provide A Diagnosis..
| 510(k) Number | K240795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2024 |
| Decision Date | June 15, 2025 |
| Days to Decision | 450 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QDA - Electrocardiograph Software For Over-the-counter Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2345 |
| Definition | An Electrocardiograph Software Device For Over-the-counter Use Creates, Analyzes, And Displays Electrocardiograph Data, And Can Provide Information For Identifying Cardiac Arrhythmias. This Device Is Not Intended To Provide A Diagnosis. |