BEUDAMED
    Product Code: PZL FDA class 2 21 CFR 878.4685

    Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

    General, Plastic Surgery

    The Extracorporeal Shock Wave Device for Treatment of Diabetic Foot Ulcers is a non-invasive device that uses extracorporeal shock waves applied externally to treat diabetic foot ulcers, promoting wound healing in patients with this complication of diabetes. It is classified as a Class 2 device under regulation 878.4685, requiring 510(k) premarket notification before marketing, and falls within the General, Plastic Surgery (SU) medical specialty. The product code is PZL. It is not an implant and is not life-sustaining.

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    510(k)s
    7
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    7
    Years Active
    8

    Basic Information

    Product Code
    PZL
    Device Class
    FDA class 2
    Regulation Number
    878.4685
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Treatment of diabetic foot ulcers

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K250779 CS-Pro MED
    K233937 OW100S
    K231710 OW100S
    K202112 Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
    K200926 OrthoGold 100
    K191961 OrthoGold
    DEN160037 dermaPACE System

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.