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510(k) Data Aggregation

    K Number
    K973979
    Device Name
    MULTI-STIM TENS, AP-101081T
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    1998-07-29

    (282 days)

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

    MULTI-STIM TENS, AP-101081T

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

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

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for two TENS devices, "Multi-Stim TENS, AP-101081T" and "Acu-Stim TENS, AP-101082T."

    Crucially, this document does not contain any information about acceptance criteria or a study proving device performance.

    A 510(k) clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, not on proving new efficacy or meeting specific performance criteria through new clinical trials as would be required for a PMA (Premarket Approval) application. The letter explicitly states: "We have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976..."

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a performance study.

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