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510(k) Data Aggregation

    K Number
    K143458
    Device Name
    Neurosplint
    Manufacturer
    Neurospectrum LLC
    Date Cleared
    2015-08-13

    (252 days)

    Product Code
    IQI, ILH
    Regulation Number
    890.3475
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neurospectrum LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An orthosis worn on the wrist With rigid insert: to limit wrist motion while worn, allowing the body to recover from the damage of repetitive motion or other injuries to immobilize and / or support for functional improvement following, repetitive motion-type of injuries such as carpal tunnel syndrome (CTS), wrist strains or sprains, and similar injuries of the wrist Without rigid insert: - . to provide wrist support - . to provide temporary relief of associated symptoms of some repetitive motion wrist conditions - to provide feedback to the user when the wrist reaches maximal flexion or extension
    Device Description
    An orthosis worn on the wrist
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