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510(k) Data Aggregation

    K Number
    K202523
    Device Name
    TMJ Relax
    Manufacturer
    Moonwalker Innovations Inc
    Date Cleared
    2021-06-24

    (296 days)

    Product Code
    OCO, MQC, PRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Moonwalker Innovations Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity
    Device Description
    TMJ Relax™ is durable medical equipment in the form of a mouthguard that is fitted to the teeth that temporarily provides traction on the mandible such that it repositions the mandible to reduce muscle tension. The device is a removeable home use product that a consumer may wear up to 22 hours per day, in other words except when eating or during sports activities. The TMJ Relax™ system is a single or series of appliances prescribed for patients with a history of a diagnosis of temporomandibular joint disorder and/or migraines/tension headaches. The device is a one-part removeable oral appliance fitted on the mandibular or maxillary teeth that repositions the mandible while sleeping or during sedentary daytime use. The appliance is patient fitted by using a computer aided manufacturing protocol.
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