BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    T1040 AKA AURAWAVE

    K Number: K124055 · Decision Jul 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    2
    Review Days
    200

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    Basic Information

    Device Name
    T1040 AKA AURAWAVE
    K Number
    K124055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Endurance Therapeutics
    Date Received
    December 31, 2012
    Decision Date
    July 19, 2013
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    Other Clearances by Endurance Therapeutics

    K Number Device Name
    K060846 THERAPEUTIC MASSAGE COMPANION