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510(k) Data Aggregation

    K Number
    K252531

    Validate with FDA (Live)

    Device Name
    Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
    Manufacturer
    Myofunctional Research Co.
    Date Cleared
    2026-03-02

    (202 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Age Range
    18 - 120
    Reference & Predicate Devices
    K132506,K191618,K111680,K182312,K231663
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Rx: The Myosa (S1H, S1, S1M, S2, S2M and S3) appliances are intended to treat snoring and/or mild to moderate obstructive sleep apnea in adults at least 18 years old.

    OTC: The Myosa for Snorers (S1, S1M and S2) are intended to treat snoring in adults at least 18 years old.

    Device Description

    The Myosa and Myosa for Snorers appliances open the airway, control over-breathing through the mouth and posture the jaw and tongue correctly during sleep. The mechanisms of use are mandibular advancement, repositioning the tongue and training nasal breathing. Models S1H, S1, S2, and S3 are pre-fabricated oral devices (mouthguards); Models S1M and S2M are moldable boil and bite devices.

    AI/ML Overview

    N/A

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