BEUDAMED
    Product Code: IKO FDA class 2 21 CFR 890.1450

    Hammer, Reflex, Powered

    Physical Medicine

    A Powered Reflex Hammer is an electrically or mechanically powered instrument used in Physical Medicine to elicit deep tendon reflexes by delivering a controlled, calibrated strike to a tendon, providing standardized neurological diagnostic assessment compared to a manual hammer. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IKO, regulated under 21 CFR 890.1450, within the Physical Medicine medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

    Research product code IKO in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    IKO
    Device Class
    FDA class 2
    Regulation Number
    890.1450
    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

    Loading...

    Related 510(k) Clearances

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

    K Number Device Name
    K904113 OPERATIVE RECORDING CAMERA

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.