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510(k) Data Aggregation

    K Number
    K032941
    Manufacturer
    Date Cleared
    2003-10-22

    (30 days)

    Product Code
    Regulation Number
    890.5850
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

    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.
    • Prevention or retardation of disuse atrophy. 2.
      1. Increasing local blood circulation.
      1. Muscle re-education.
      1. Maintaining or increasing range of motion.
    • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6.

    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.

    Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

      1. Relief of pain
      1. Muscle spasms
      1. Joint contractures

    But NOT for the treatment of malignancies

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a Letter of Substantial Equivalence from the FDA for a device called "Rich-Mar AutoSound 7.6". This document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

    The letter essentially states that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. It lists the indications for use of the device but offers no performance metrics, study designs, or data to support any acceptance criteria.

    Therefore, I cannot provide the requested information based on the input text.

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