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    K Number
    K172971
    Device Name
    BMLS16-1
    Manufacturer
    BioMedical Life Systems, Inc.
    Date Cleared
    2018-07-08

    (285 days)

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

    BMLS16-1

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

    The BMLS16-1 Transcutaneous Electrical Nerve Stimulation (TENS) device is used for the symptomatic relief and management of chronic (long-term) intractable pain.

    Device Description

    Transcutaneous Electrical Nerve Stimulator For Pain Relief

    AI/ML Overview

    This is a 510(k) premarket notification for a Class II medical device, specifically a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The provided document is an FDA letter of clearance and the "Indications for Use" section. This type of document typically does not contain the detailed study information regarding acceptance criteria and performance data as it is a summary of the FDA's decision, not the full submission.

    Therefore, based only on the provided text, I cannot answer the questions about acceptance criteria and study details. The letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device's performance was compared to a predicate device, but the specifics of that comparison, including acceptance criteria and study details, are not present in this document.

    To answer your questions, I would need to review the full 510(k) submission, which is not provided here.

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