K243236 is an FDA 510(k) clearance for the WHOOP ECG (electrocardiogram) Feature (1.0). This device is classified as a Electrocardiograph Software For Over-the-counter Use (Class II - Special Controls, product code QDA).
Submitted by Whoop., Inc. (Boston, US). The FDA issued a Cleared decision on April 4, 2025, 176 days after receiving the submission on October 10, 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 | K243236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2024 |
| Decision Date | April 04, 2025 |
| Days to Decision | 176 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. |