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510(k) Data Aggregation

    K Number
    K181396
    Device Name
    Oral Device OA, Oral Device S
    Manufacturer
    Passion for Life Healthcare (UK) Limited
    Date Cleared
    2018-11-16

    (171 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Passion for Life Healthcare (UK) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oral Device-OA is intended to reduce night-time snoring and / or mild to moderate obstructive sleep apnea (OSA) for adults 18 and older. The Oral Device-S is intended to reduce night time snoring for adults 18 and older.
    Device Description
    Passion for Life Healthcare UK Limited is offering two devices: 1) the Oral Device-S is an OTC device intended as an aid for the reduction of snoring; and 2) the Oral Device-OA is a Rx device intended as an aid for the reduction of mild to moderate obstructive sleep apnea, and/or snoring. Both the Oral Device-S and Oral Device-OA are an oral appliance design concept based upon the use of a standard set of upper and lower trays of one size. The Oral Device-OA is fitted by a dentist to act as a Mandibular Repositioning Device (MRD). Whereas the Oral Device-S, an OTC device, is fitted by the user at home and any adjustments can be made without clinician interaction.
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