BEUDAMED
    Product Code: FQJ FDA class 1 21 CFR 880.5820

    Support, Scrotal, Therapeutic

    General Hospital

    The Therapeutic Scrotal Support is a device worn to support the scrotum, reduce discomfort, and promote healing following scrotal surgery, injury, or conditions such as orchitis or epididymitis. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FQJ, regulated under 21 CFR 880.5820 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.

    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
    FQJ
    Device Class
    FDA class 1
    Regulation Number
    880.5820
    Medical Specialty
    General Hospital
    Review Panel
    HO
    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 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.