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

    KOREBALANCE (KINESTHETIC ABILITY TRAINER)

    K Number: K070676 · Decision Apr 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    37

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    Basic Information

    Device Name
    KOREBALANCE (KINESTHETIC ABILITY TRAINER)
    K Number
    K070676
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sportkat, LLC
    Date Received
    March 12, 2007
    Decision Date
    April 18, 2007
    Product Code
    LXV
    Advisory Committee
    Unknown
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LXV Apparatus, Vestibular Analysis

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