Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K081787
    Device Name
    CAMLAB CRANIAL ORTHOSIS HELMET
    Manufacturer
    BIOSCULPTOR CORPORATION
    Date Cleared
    2009-01-27

    (217 days)

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

    BIOSCULPTOR CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.
    Device Description
    The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. This orthosis is only available if prescribed by a physician. The initial geometry of the patient is acquired from either laser scanned measurements using the BioScanner (a.k.a. Polhemus Fastscan handheld laser scanner) or via traditional casting methods. If a cast is taken, the cast will be scanned with the BioScanner as well. The resulting three dimensional model along with a digital order form and any other pertinent information is then sent to BioSculptor Corporation via email or secured internet application. Utilizing this information, the BioSculptor CAD/CAM system will then create a positive mold representative of the patient scan. This positive model will then be used to create the orthosis. Each orthosis consist of a plastic outer shell, a foam inner shell, a strap and fastener to secure the orthosis. The practitioner modifies the orthosis to achieve an accurate fit and monitors the progress to ensure that no adverse effects occur.
    Ask a Question

    Page 1 of 1