BEUDAMED
    Product Code: KFW FDA class 1 21 CFR 890.3420

    Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered

    Physical Medicine

    Powered Shoulder, Elbow, Forearm, Wrist, and Hand Assembly is a motorized upper-limb prosthetic component system that uses electric or other power sources to actuate one or more upper extremity joints and segments, providing active movement for patients with upper limb loss or impairment. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KFW, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KFW
    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 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.