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

    SPINE LINE

    K Number: K922366 · Decision Jul 13, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    176
    Registration Numbers
    176
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    54

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    Basic Information

    Device Name
    SPINE LINE
    K Number
    K922366
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dambrecine, Inc.
    Date Received
    May 20, 1992
    Decision Date
    July 13, 1992
    Product Code
    LYG
    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
    LYG Massager, Therapeutic, Manual

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