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

    TMJ Relax

    K Number: K202523 · Decision Jun 24, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    296

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    Basic Information

    Device Name
    TMJ Relax
    K Number
    K202523
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Moonwalker Innovations, Inc.
    Date Received
    September 1, 2020
    Decision Date
    June 24, 2021
    Product Code
    OCO
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCO Mouthguard, Migraine/Tension Headache

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