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510(k) Data Aggregation

    K Number
    K151558
    Device Name
    Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
    Manufacturer
    NEUROTHERAPIES RESET GMBH.
    Date Cleared
    2016-01-20

    (224 days)

    Product Code
    KLW
    Regulation Number
    874.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROTHERAPIES RESET GMBH.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Desyncra™ for Tinnitus Therapy System is intended to provide relief from the disturbance of subjective tinnitus while using the system. With regular use (over several months) as part of a tinnitus management program it may provide relief to the patient when not using the system. The Desyncra™ for Tinnitus Therapy System is a patient device for home use. The Desyncra™ for Tinnitus Therapy System is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment. Stimulation needs to be applied for several hours a day over a period of weeks or months. The target population is adults over 18 years of age.
    Device Description
    Not Found
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