BEUDAMED
    Product Code: ISW FDA class 2 21 CFR 890.3500

    Assembly, Knee/Shank/Ankle/Foot, External

    Physical Medicine

    A knee/shank/ankle/foot external assembly is a modular lower limb prosthetic subassembly integrating knee joint, structural shank, ankle, and foot components into a unified unit for transfemoral amputees. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is ISW, regulated under 21 CFR 890.3500, within the Physical Medicine medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    ISW
    Device Class
    FDA class 2
    Regulation Number
    890.3500
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K991590 C-LEG (3C100)

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.