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510(k) Data Aggregation

    K Number
    K250756

    Validate with FDA (Live)

    Device Name
    Pression Wave PRO External Counter-Pulsation System
    Manufacturer
    Pression, Inc.
    Date Cleared
    2025-12-22

    (285 days)

    Product Code
    DRN
    Regulation Number
    870.5225
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    35 - 78
    Reference & Predicate Devices
    K190683,K022107,K152115,K042413
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K190683, K022107, K152115

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pression Wave PRO External Counter-Pulsation System is indicated for the treatment of chronic stable angina (CSA) that is refractory to optimal anti-anginal medical therapy and without options for revascularization in adult patients that weigh greater than 40kg. In addition, it is intended for use in healthy adult patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the supervision of a healthcare professional.

    Device Description

    External counter-pulsation (ECP) as a general technology involves the application of pressure to the patient's legs using inflatable cuffs or sleeves to enhance perfusion at the heart. ECP using the Wave PRO involves wrapping the patient's calves in sleeves containing inflatable bladders, which compress the calves in sync with the patient's cardiac cycle. During diastole, a series of five bladders within the sleeves inflate sequentially from the patient's ankles towards their knees. This compression results in diastolic augmentation, which is observable from the pulse data obtained using a finger-tip PPG sensor. During the diastolic phase, the heart is relaxed, allowing for coronary perfusion to the cardiac muscle. By compressing the inflatable bladders during this portion of the cardiac cycle, aortic retrograde flow is increased, allowing for enhanced coronary perfusion.

    The Pression Wave PRO System consists of three primary subsystems: 1) the Compression Control System, which controls the flow of compressed air to the sleeves, measures the phase of the cardiac cycle, and provides the graphical user interface (GUI); 2) Patient-Worn Calf Sleeves, which direct the compressive force of compressed air, delivered comfortably and consistently, to the patient's calf muscles; and 3) the Compression Timing Algorithm (Software), which determines when the patient's heart is in diastole, using a photoplethysmography (PPG) sensor, and controls the timed application of compression to the patient's calf muscles.

    AI/ML Overview

    N/A

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