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510(k) Data Aggregation

    K Number
    K992911
    Device Name
    MAGSTIM RAPID
    Manufacturer
    MAGSTIM CORPORATION US
    Date Cleared
    2000-01-07

    (130 days)

    Product Code
    GWF
    Regulation Number
    882.1870
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAGSTIM CORPORATION US

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Stimulation of peripheral nerves.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the Magstim Rapid device. It states that the device is substantially equivalent to legally marketed predicate devices for the indication of "Stimulation of peripheral nerves."

    However, this document does not contain any information regarding acceptance criteria, device performance metrics, study designs (e.g., sample sizes, ground truth establishment, expert qualifications, or MRMC studies), or specific results of any performance studies.

    Therefore, I cannot fulfill your request for the information outlined in your prompt using only the provided text. The document is an administrative clearance letter, not a technical report detailing performance assessment.

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