K243981 is an FDA 510(k) clearance for the Hexoskin Medical System (7100-00016). This device is classified as a Transmitters And Receivers, Electrocardiograph, Telephone (Class II - Special Controls, product code DXH).
Submitted by Carre Technologies, Inc. (Montreal, CA). The FDA issued a Cleared decision on November 18, 2025, 330 days after receiving the submission on December 23, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.
| 510(k) Number | K243981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2024 |
| Decision Date | November 18, 2025 |
| Days to Decision | 330 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXH - Transmitters And Receivers, Electrocardiograph, Telephone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2920 |