BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Pression Wave PRO External Counter-Pulsation System

    K Number: K250756 · Decision Dec 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    285

    Basic Information

    Device Name
    Pression Wave PRO External Counter-Pulsation System
    K Number
    K250756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5225
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pression, Inc.
    Date Received
    March 12, 2025
    Decision Date
    December 22, 2025
    Product Code
    DRN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRN Device, Counter-Pulsating, External

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