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FDA 510(k)

Pression Wave PRO External Counter-Pulsation System

K-Number: K250756 · 2025-12-22

ApplicantPression, Inc.
Decision Date2025-12-22
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pression Wave PRO External Counter-Pulsation System is a medical device manufactured by Pression, Inc.. It received FDA 510(k) clearance on 2025-12-22 under approval number K250756. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pression Wave PRO External Counter-Pulsation System?

Pression Wave PRO External Counter-Pulsation System is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Pression, Inc.. The 510(k) number is K250756.

When was Pression Wave PRO External Counter-Pulsation System approved by the FDA?

Pression Wave PRO External Counter-Pulsation System received FDA 510(k) clearance on 2025-12-22, under approval number K250756.

What company makes Pression Wave PRO External Counter-Pulsation System?

Pression Wave PRO External Counter-Pulsation System is manufactured by Pression, Inc..

What is the FDA product code for Pression Wave PRO External Counter-Pulsation System?

The FDA product code for Pression Wave PRO External Counter-Pulsation System is DRN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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