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

    AMERICAN MEDICAL MFG. LUMBAR CPM

    K Number: K922493 · Decision Jul 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    159
    Applicant Total
    3
    Review Days
    61

    Basic Information

    Device Name
    AMERICAN MEDICAL MFG. LUMBAR CPM
    K Number
    K922493
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    AMERICAN MEDICAL CORP.
    Date Received
    May 27, 1992
    Decision Date
    July 27, 1992
    Product Code
    BXB
    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
    BXB Exerciser, Powered

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