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    K Number
    K013770
    Device Name
    MODIFICATION TO: WINNER ST-2 STIMULATOR
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    2002-01-18

    (66 days)

    Product Code
    IPF,GZJ,LIH
    Regulation Number
    890.5850
    Type
    Special
    Panel
    Physical Medicine (PM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO: WINNER ST-2 STIMULATOR

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

    Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:

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

    Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:

      1. Symptomatic relief of chronic intractable pain.
      1. Management of pain associated with post-traumatic or post operative conditions.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Rich-Mar Winner ST-2, a muscle stimulator and TENS unit). It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details you requested regarding a medical device study.

    Therefore, I cannot extract the requested information from the given text. This document serves as regulatory clearance based on substantial equivalence to predicate devices, not a detailed report of a performance study.

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