BEUDAMED
    Product Code: QKC FDA class 2 21 CFR 890.5360

    Interactive Rehabilitation Exercise Device, Prescription Use

    Physical Medicine

    The Interactive Rehabilitation Exercise Device, Prescription Use is a Class 2 physical medicine device intended to provide an interactive rehabilitation environment by delivering exercises for patients to perform, requiring a prescription for use. It is exempt from 510(k) premarket notification under 21 CFR 890.5360 within the Physical Medicine medical specialty. The product code is QKC. The device is not an implant and is not flagged as life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    39
    Registration Numbers
    39
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QKC
    Device Class
    FDA class 2
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    4

    Device Characteristics

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

    Definition

    A prescription device intended to provide interactive rehabilitation environment by providing exercises for users to perform.

    FEI Numbers

    This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.