BEUDAMED
    Product Code: FZK FDA class 1 21 CFR 878.4950

    Chair, Surgical, Non-Electrical

    General, Plastic Surgery

    The Chair, Surgical, Non-Electrical (product code FZK) is a non-powered chair designed for use in surgical settings, providing patient or operator positioning support during procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls such as proper labeling and good manufacturing practices, with no premarket notification required. The device falls under 21 CFR 878.4950 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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    510(k)s
    2
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    2
    Years Active
    12

    Basic Information

    Product Code
    FZK
    Device Class
    FDA class 1
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K962528 OLYMPUS MOBILE CHAIR/COUCH
    K842030 NEUTRAL POS-CHAIR SURGEON CHAIR

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.