BEUDAMED
    Product Code: FIA FDA class 1 21 CFR 876.5820

    Chair, Dialysis, Unpowered, Without Scales

    Gastroenterology, Urology

    The Unpowered Dialysis Chair Without Scales is a non-motorized seating device designed to position and support patients during hemodialysis sessions, without integrated weighing capability. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is FIA, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology medical specialty.

    View on FDA
    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    FIA
    Device Class
    FDA class 1
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.