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510(k) Data Aggregation

    K Number
    K233485
    Device Name
    M-Wave
    Manufacturer
    Zynex Medical Inc.
    Date Cleared
    2024-01-26

    (91 days)

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

    M-Wave

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

    This Zynex device has been designed for muscle re-education, prevention of disuse atrophy, increase local blood circulation, maintain, or increase range of motion, and relaxation of muscle spasms.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a device called "M-Wave," a powered muscle stimulator. It outlines the regulatory approval process and requirements but does not detail any performance studies, acceptance criteria tables, or specifics on how the device's efficacy was verified. Therefore, I cannot fulfill your request for that specific information based on the given input.

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