BEUDAMED
    Product Code: GBB FDA class 1 21 CFR 878.4960

    Chair, Surgical, Ac-Powered

    General, Plastic Surgery

    The Chair, Surgical, AC-Powered (product code GBB) is an electrically powered chair used in surgical settings to position patients or clinicians during procedures, providing adjustable support controlled by an AC power source. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4960 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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    510(k)s
    8
    FEI Numbers
    45
    Registration Numbers
    45
    Unique Applicants
    6
    Years Active
    15

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    Basic Information

    Product Code
    GBB
    Device Class
    FDA class 1
    Regulation Number
    878.4960
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K964102 TENET TIBIAL FRACTURE SUPPORT
    K893598 HYDRAULIC FOOT OPERATED STOOL
    K831385 LITHOTOMY CHAIR #415
    K831325 NUTROMAT
    K822264 NAGASHIMA SN OPERATOR'S CHAIR
    K822251 EXAMINATION & TREATMENT CHAIRS
    K822013 NAGASHIMA SN AUTOMATIC TREATMENT CHAIR
    K820636 STORZ #6500 POWER EXAMINATION CHAIR

    FEI Numbers

    This FDA classification entry is associated with 45 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 45 registration numbers. Click on an entry to view related FDA registrations.