BEUDAMED
    Product Code: ISP FDA class 1 21 CFR 890.3420

    Valve, Prosthesis

    Physical Medicine

    A prosthesis valve is a functional component used in prosthetic limb systems, typically in suction suspension sockets, to control air flow and maintain the seal between the residual limb and the prosthetic socket. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISP, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty. This device is GMP exempt.

    View on FDA
    510(k)s
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    ISP
    Device Class
    FDA class 1
    Regulation Number
    890.3420
    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
    K843855 ERGOTEST 40 & 45

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.