BEUDAMED
    Product Code: FQK FDA class 1 21 CFR 880.5160

    Binder, Perineal

    General Hospital

    A perineal binder is a supportive garment worn around the perineal region, typically used in post-surgical or post-partum care to provide compression and stabilization. It is classified as FDA Class 1 (lowest risk), meaning it is subject only to general controls with no premarket submission required. The product code is FQK, regulated under 21 CFR 880.5160, within the General Hospital medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.

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    510(k)s
    0
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    FQK
    Device Class
    FDA class 1
    Regulation Number
    880.5160
    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 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.