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510(k) Data Aggregation

    K Number
    K100246
    Device Name
    MAX-IF1000
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2010-11-24

    (301 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MAX-IF1000

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

    The MAX-IF1000 interferential stimulator is used for symptomatic relief and management of chronic pain and/or an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

    Device Description

    MAX-IF1000 Interferential Stimulator

    AI/ML Overview

    The provided text is a US FDA 510(k) clearance letter for the MAX-IF1000 Interferential Stimulator. It does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

    The letter primarily:

    • Identifies the device and applicant.
    • States that the device has been found substantially equivalent to a legally marketed predicate device.
    • Outlines general regulatory requirements for marketed devices (e.g., registration, labeling, good manufacturing practice).
    • Provides contact information for various FDA divisions.
    • Includes an "Indications for Use" statement for the device.

    Therefore, I cannot provide the requested information based on the input text. The text is a regulatory clearance document, not a scientific study report or clinical trial summary.

    To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or the relevant sections from a 510(k) submission that details performance testing.

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