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510(k) Data Aggregation

    K Number
    K023572
    Device Name
    LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
    Date Cleared
    2003-01-13

    (81 days)

    Product Code
    Regulation Number
    882.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    REHABILITATION INSTITUTE,LOMA LINDA UNIVERSITY MED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LLUMC Cranial Remolding Helmet is a cranial orthosis that is intended for use on infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The device is intended to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. It is indicated for prescription use.
    Device Description
    The LLUMC Cranial Remolding Helmet is a cranial orthosis used to treat children 3-18 months of age for moderate to severe non-synostotic plagiocephaly, brachycephally, and scaphocephally. The LLUMC Cranial Remolding Helmet is fabricated from a cast impression of the infant's cranium, taken by a certified orthotist (CO). The negative cast impression is converted by the CO into a positive impression and rectified into the desired corrected shape. The helmet is then formed over the corrected positive mold by a registered orthotic technician (RTO). A 1/4" polyethylene form (Volara) is used as an interface (liner) material, and 3/16" sheet of polyethylene plastic is used as the outer shell. The helmet is then trimmed by the RTQ, as necessary to not obstruct the infant's vision, hearing, ability to breathe or restrict movement of the head and neck. Ventilation holes are added to reduce heat retention. The CO fits the Cranial Remolding Helmet to the infant. The Cranial Remolding Helmet provides a gentle pressure over the prominent areas of the cranium in an effort to slow the growth in these areas. Voids are provided in an effort to encourage growth over the flat areas and reduce deformity. The infant is then evaluated monthly by the CO to monitor growth and insure that a precise fit is maintained. Adjustments are made to the device as needed to accommodate growth and/or optimize the function of the helmet.
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