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

    HOOKING SYSTEM

    K Number: K930613 · Decision Jul 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    176
    Registration Numbers
    176
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    522

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    Basic Information

    Device Name
    HOOKING SYSTEM
    K Number
    K930613
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alain Machtelinckx
    Date Received
    February 5, 1993
    Decision Date
    July 12, 1994
    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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