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510(k) Data Aggregation

    K Number
    K233035
    Device Name
    Electronic Muscle Stimulator (Model MP01)
    Manufacturer
    Shenzhen Hengbosi Industrial Co., Ltd.
    Date Cleared
    2024-01-08

    (105 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Hengbosi Industrial Co., Ltd.

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

    Electronic Muscle Stimulator is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, toning and firming of arms and legs.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for an Electronic Muscle Stimulator. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study-related details you've requested.

    The document confirms that the device (Electronic Muscle Stimulator, Model: MP01) is substantially equivalent to legally marketed predicate devices for specific indications for use:

    • Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
    • Strengthening, toning, and firming of arms and legs.

    It also notes that the device is intended for Over-The-Counter Use.

    To answer your request, I would need a different document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that details the device's performance against specific acceptance criteria.

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