Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990871
    Device Name
    PILLOWPOSITIVE CERVICAL PILLOW
    Manufacturer
    LIFESLEEP SYSTEMS, INC.
    Date Cleared
    1999-06-10

    (86 days)

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

    LIFESLEEP SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PillowPositive Cervical Pillow ("PillowPositive") is intended for the reduction of symptoms (apnea/hypopnea) associated with mild obstructive sleep apnea by maintaining an open upper airway during sleep. PillowPositive Cervical Pillow ("PillowPositive") is indicated for the reduction of symptoms (apneas and hypopneas) associated with mild obstructive sleep apnea.
    Device Description
    The pillow consists of a custom-fitted high resiliency urethane foundation, an overlying "memory foam" supporting the head and neck, a stretch terry-cloth cover, and removable foam inserts. The PillowPositive is comprised of a thin central area for supine sleeping and two thicker, sloped side panels with earwells for side sleeping.
    Ask a Question

    Page 1 of 1