K250756 is an FDA 510(k) clearance for the Pression Wave PRO External Counter-Pulsation System. This device is classified as a Device, Counter-pulsating, External (Class II - Special Controls, product code DRN).
Submitted by Pression, Inc. (Coatesville, US). The FDA issued a Cleared decision on December 22, 2025, 285 days after receiving the submission on March 12, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5225.
| 510(k) Number | K250756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2025 |
| Decision Date | December 22, 2025 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRN - Device, Counter-pulsating, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5225 |