BEUDAMED
    Product Code: INY FDA class 1 21 CFR 890.5180

    Bed, Patient Rotation, Manual

    Physical Medicine

    A Manual Patient Rotation Bed is a non-powered therapeutic bed used in Physical Medicine that allows the patient to be manually repositioned through rotational turning, used to prevent pressure ulcers and pulmonary complications associated with immobility in bed-confined patients. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is INY, regulated under 21 CFR 890.5180, within the Physical Medicine medical specialty.

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    510(k)s
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    INY
    Device Class
    FDA class 1
    Regulation Number
    890.5180
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    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
    K851875 KINNET

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.