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510(k) Data Aggregation

    K Number
    K193383
    Device Name
    SnugKap
    Manufacturer
    HeadStart, Ltd.
    Date Cleared
    2021-06-07

    (550 days)

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

    HeadStart, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SnugKap is intended for medical purposes 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 by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.
    Device Description
    The SnugKap devices are cranial orthoses intended to be utilized on infant patients that suffer from head shape abnormalities. The SnugKap devices are additively manufactured from a 3D scan file of the patient's head. The scan file is digitally modified to address the anatomical/shape abnormalities in the skull. The SnugKap is then 3D printed and fabricated according to the case plan approved by the orthotist. The SnugKap is manufactured from a copolymer made of polylactic acid; additional parts are made of a variety of materials including thermoplastic polyurothane, polypropylene, and Plastazote® (white or pink) polymer foam.
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