BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BERKELEY CHAIR

    K Number: K823085 · Decision Jan 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    6
    Review Days
    94

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    Basic Information

    Device Name
    BERKELEY CHAIR
    K Number
    K823085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Berkeley Electric Wheelchair Co.
    Date Received
    October 19, 1982
    Decision Date
    January 21, 1983
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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    Other Clearances by Berkeley Electric Wheelchair Co.

    K Number Device Name
    K823877 BERKELEY HARNESS
    K823874 BERKELEY BRAKE
    K823873 CHAIN SILENCER
    K823876 BERKELEY FORK
    K823875 CHAIN KIT