BEUDAMED
    Product Code: IQZ FDA class 1 21 CFR 890.3420

    Hand, External Limb Component, Powered

    Physical Medicine

    A powered external limb component hand is a motorized prosthetic terminal device designed to replicate the appearance and function of a natural hand for upper limb amputees, using electrical power for grasp and release. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQZ, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty. This device is GMP exempt.

    View on FDA
    510(k)s
    0
    FEI Numbers
    36
    Registration Numbers
    36
    Unique Applicants
    0
    Years Active
    —

    Research product code IQZ 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
    IQZ
    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

    FEI Numbers

    This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.