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510(k) Data Aggregation

    K Number
    K982221
    Device Name
    PREMIER AP
    Manufacturer
    AMERICAN IMEX
    Date Cleared
    1998-09-22

    (90 days)

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

    PREMIER AP

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

    Transcutaneous Electrical Nerve Stimulaton (TENS) devices are to be used for the symptomatic relief and management of chronic (long term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Premier A-P," which is a Transcutaneous Electrical Nerve Stimulation (TENS) device. The letter states that the device is substantially equivalent to devices marketed before May 28, 1976.

    Based on the provided document, the following questions cannot be answered as the document is an FDA clearance letter and does not contain detailed study information regarding acceptance criteria or device performance. This type of information is typically found in the 510(k) submission summary or a separate clinical study report, neither of which are provided here.

    Therefore, for all the items requested (1 to 9), the answer is: The information is not available in the provided FDA 510(k) clearance letter.

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