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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
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neurospectrum LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter for a device called "Neurosplint," outlining its indications for use and regulatory information. It does not include details about device performance metrics, study designs, sample sizes, or expert involvement as requested.

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