BEUDAMED
    Product Code: OYS FDA class 1 21 CFR 880.6760

    Patient Bed With Canopy/Restraints

    General Hospital

    The Patient Bed with Canopy/Restraints is a general hospital device consisting of an enclosed bed canopy system used as a passive restraint to prevent patients from falling or exiting the bed. It is classified as Class 1 (FDA Class 1), subject to general controls, under regulation number 880.6760 in the General Hospital medical specialty. The product code is OYS and no 510(k) premarket notification is required for this device.

    View on FDA
    510(k)s
    3
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    1
    Years Active
    1

    Basic Information

    Product Code
    OYS
    Device Class
    FDA class 1
    Regulation Number
    880.6760
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    4

    Device Characteristics

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

    Definition

    Enclosed bed canopy system used as passive restraint.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K113355 POSEY BED
    K113357 POSEY BED
    K103817 POSEY BED

    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.