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510(k) Data Aggregation

    K Number
    K003258
    Device Name
    MS-ONE, MODEL MS-1
    Manufacturer
    HOME WELLNESS WEST
    Date Cleared
    2001-01-12

    (86 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K994065
    Device Name
    MS-ONE, MODEL MS-1
    Manufacturer
    HOME WELLNESS WEST
    Date Cleared
    2000-04-04

    (125 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    THE INDICATIONS FOR USE OF THIS POWERED MUSCLE STIMULATOR FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS:

    • Relaxation of muscle spasms
    • Prevention of retardation of disuse atrophy
    • Increasing local blood circulation
    • Muscle re-education
    • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
    • Maintaining or increasing range of motion
    Device Description

    POWERED MUSCLE STIMULATOR

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "MS-One (MS-1)," a powered muscle stimulator. It does not contain information about acceptance criteria, a study that proves the device meets those criteria, or details regarding ground truth, sample sizes, or expert adjudication as requested in your prompt.

    The document only states the "Indications for Use" for which substantial equivalence was sought and granted. These are:

    • Relaxation of muscle spasms
    • Prevention of retardation of disuse atrophy
    • Increasing local blood circulation
    • Muscle re-education
    • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
    • Maintaining or increasing range of motion

    Therefore, I cannot provide the requested table or answer the specific questions about the study, ground truth, sample sizes, or expert involvement because that information is not present in the provided text. This document is a regulatory approval letter, not a scientific study report.

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