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510(k) Data Aggregation

    K Number
    K100160
    Device Name
    ZZOMA POSITIONAL SLEEPER MODEL 001
    Manufacturer
    SLEEP SPECIALISTS, LLC
    Date Cleared
    2010-05-11

    (111 days)

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

    SLEEP SPECIALISTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZZOMA Positional Sleeper is indicated for use and intended for professional use for the treatment of mild to moderate, predominantly positional obstructive sleep apnea (OSA) and to reduce or alleviate snoring. The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use.
    Device Description
    The ZZOMA Positional Sleeper is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam (Figures 1 and 2). It is contained in a backpack type material with an associated Velcro® elastic belt. The device is worn on the back, with the elastic belts brought around each side of the subject and secured anteriorly with the adjustable straps. The particular size and wedge-shaped design on both sides of this device keeps the subject comfortably positioned on their side, and prevents him/her from assuming the supine position. The ZZOMA has a firm inner core made of foam and the outer part of the device is covered in nylon, and the part that touches the subject's body is cotton covered with a coating of PVC dots that help keep the ZZOMA in place while you sleep.
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