BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PERSONAL SITZ BATH KIT

    K Number: K800958 · Decision May 2, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    6
    Applicant Total
    29
    Review Days
    9

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    Basic Information

    Device Name
    PERSONAL SITZ BATH KIT
    K Number
    K800958
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5125
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    The Healthcare Group Laboratories, Inc.
    Date Received
    April 23, 1980
    Decision Date
    May 2, 1980
    Product Code
    KTC
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KTC Bath, Sitz, Nonpowered

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