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510(k) Data Aggregation

    K Number
    K041388
    Device Name
    COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2004-11-23

    (182 days)

    Product Code
    GZJ,IPF,LIH
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K041300
    Why did this record match?
    Device Name :

    COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1

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

    Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Interferential Mode: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain. TENS Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

    Device Description

    Combination Electrical Neuromuscular Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator (TENS), Model BMLS04-1

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Combination Electrical Neuromuscular Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator (TENS), Model BMLS04-1). This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot fulfill your request for the detailed information you asked for, such as:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for the test set and data provenance.
    • Number of experts and their qualifications for ground truth.
    • Adjudication method.
    • MRMC comparative effectiveness study results or effect size.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Sample size and ground truth establishment for the training set.

    The document states that the device was found substantially equivalent to legally marketed predicate devices, meaning it met the requirements through comparison with existing approved devices, rather than through a direct study demonstrating its performance against predefined acceptance criteria in the way you've described.

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