Pression Wave PRO External Counter-Pulsation System— 510(k) K250756

Name: FDA 510(k) clearance K250756
Creator: U.S. Food and Drug Administration
Published: 2025-12-22

Substantially Equivalent

Pression, Inc.

FDA 510(k) clearance K250756 for Pression Wave PRO External Counter-Pulsation System, Substantially Equivalent on 2025-12-22. Applicant: Pression, Inc.. Device class: 2.

Clearance details

Applicant: Pression, Inc.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2025-03-12
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coatesville, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.