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

    MECHANICAL CHAIR

    K Number: K820591 · Decision Mar 15, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    7
    Applicant Total
    12
    Review Days
    11

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    Basic Information

    Device Name
    MECHANICAL CHAIR
    K Number
    K820591
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Kaye Products, Inc.
    Date Received
    March 4, 1982
    Decision Date
    March 15, 1982
    Product Code
    LBE
    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
    LBE Stroller, Adaptive

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