LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082367
    Device Name
    INFANT SLEEP BEANIE
    Manufacturer
    LIFE INNOVATIONS LLC
    Date Cleared
    2009-06-12

    (298 days)

    Product Code
    FRP
    Regulation Number
    880.5680
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE INNOVATIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Life Innovations Infant Sleep Beanie is an over-thecounter repositioning device to aid in the prevention of deformational (or positional) plagiocephaly arising from consistent back-sleeping postures. The Infant Sleep Beanie is intended for healthy, non-ambulating infants 0-9 months of age.
    Device Description
    The Life Innovations Infant Sleep Beanie is a form fitting infant beanie hat placed strategically on a baby's head while lying awake, sleeping or during travel.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1