BEUDAMED
    Product Code: FPS FDA class 1 21 CFR 880.6070

    Board, Bed

    General Hospital

    The Bed Board is a rigid flat panel placed under a mattress or on a bed frame to provide a firm sleeping surface, used in clinical settings for patients requiring back support or spinal alignment. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FPS, regulated under 21 CFR 880.6070 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.

    View on FDA
    510(k)s
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FPS
    Device Class
    FDA class 1
    Regulation Number
    880.6070
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K780230 BED BOARD

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.