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510(k) Data Aggregation

    K Number
    K040306
    Device Name
    HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2004-03-23

    (43 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7

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

    High Voltage Pulsed Stimulation 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.

    Device Description

    High Volt Pulsed Current Stimulator For Muscle Reeducation - Class II Model BMLS02-7

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a High Voltage Pulsed Stimulator. It does not contain any information about acceptance criteria, device performance, study details, ground truth, or sample sizes as requested in your prompt.

    The letter solely states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed, subject to general controls and other applicable regulations.

    Therefore, I cannot provide the requested information based on this document.

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