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

    X-FORCE

    K Number: K111557 · Decision Nov 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    160

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    Basic Information

    Device Name
    X-FORCE
    K Number
    K111557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seven Seas Distribtion and Manufacturing, LLC
    Date Received
    June 3, 2011
    Decision Date
    November 10, 2011
    Product Code
    NYN
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NYN Stimulator, Electrical, Transcutaneous, For Arthritis

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