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510(k) Data Aggregation

    K Number
    K082367
    Device Name
    INFANT SLEEP BEANIE
    Date Cleared
    2009-06-12

    (298 days)

    Product Code
    Regulation Number
    880.5680
    Why did this record match?
    Product Code :

    FRP

    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.
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    K Number
    K090284
    Device Name
    RES-Q INFANT WEDGE AND SLING
    Date Cleared
    2009-06-05

    (120 days)

    Product Code
    Regulation Number
    880.5680
    Why did this record match?
    Product Code :

    FRP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RES-Q Infant Wedge & Sling is designed to allow babies 0-12 months with gastroesophageal reflux to rest comfortably in a semi-upright position; it is used for sleeping and playtime in supine, prone, and side-lying positions.
    Device Description
    Device Name: RES-Q Infant Wedge & Sling Classification/Common Name: Holder, Infant Positioner Code FRP, CFR 880.5680 Class 1
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    K Number
    K062143
    Device Name
    KOZY COMFORT INFANT POSITIONER
    Date Cleared
    2006-10-24

    (89 days)

    Product Code
    Regulation Number
    880.5680
    Why did this record match?
    Product Code :

    FRP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kozy Comfort product is indicated for healthy infants 0-12 months to aid in the prevention of skull deformities that may arise from consistent back-sleeping postures, namely the condition know as deformational (or positional) plagiocephaly
    Device Description
    Kozy Comfort™ Infant Positioner is a polyurethane based infant positioner.
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    K Number
    K060986
    Device Name
    HEAD BED
    Date Cleared
    2006-07-11

    (92 days)

    Product Code
    Regulation Number
    880.5680
    Why did this record match?
    Product Code :

    FRP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Head Bed™ infant positioner is indicated for infants aged 0-6 months to aid in the prevention of deformational plagiocephaly.
    Device Description
    The Head Bed device is a U-shaped soft polyurethane foam cushion covered in flame retardant cloth material. Outside dimensions are 17.5cm (w) x 18.5cm (1) x 4cm (h). Inside dimensions are 13.5cm (h) x 6.5cm (w). The device is adequately soft so as to provide support for the infants head without being abrasive. The removable cloth cover is flame retardant and machine washable.
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    K Number
    K051300
    Device Name
    ROBIN HOOD VEST
    Manufacturer
    Date Cleared
    2005-12-08

    (204 days)

    Product Code
    Regulation Number
    880.5680
    Why did this record match?
    Product Code :

    FRP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Robin Hood Vest ™ is intended for use in healthy infants aged 0-15 months to aid in the prevention of skull deformities that can arise from consistent back-sleeping postures, the condition known as deformational (or positional) plagiocephaly.
    Device Description
    The Robin Hood Vest ™ is a sleeveless vest, with a pocket on the back for an insertable foam wedge, that an infant wears while sleeping. The device positions a foam wedge under the infant during sleep to direct the head so that it does not always rest on the same spot.
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    K Number
    K041996
    Device Name
    NIGHTFORM
    Date Cleared
    2004-08-03

    (8 days)

    Product Code
    Regulation Number
    880.5680
    Why did this record match?
    Product Code :

    FRP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NightForm product is indicated for healthy infants 0-9 months to aid in the prevention of skull deformities that can rise from consistent back-sleeping postures, known as Deformational (or positional) plagiocephaly.
    Device Description
    NightForm is a fabric-covered polyurethane foam mattress with two accompanying fabric-covered polyurethane wedges that affix to the mattress by hook/loop fasteners in various positions that permit parents to modify nightly the supine sleeping position of their sleeping infants and thereby prevent a condition known as deformational plagiocephaly.
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    K Number
    K003511
    Device Name
    KENDALL-LTP TURNER SAVE-A-LINE
    Date Cleared
    2001-01-24

    (71 days)

    Product Code
    Regulation Number
    880.5680
    Why did this record match?
    Product Code :

    FRP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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