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510(k) Data Aggregation

    K Number
    K253408

    Validate with FDA (Live)

    Device Name
    CoolTone
    Manufacturer
    Zimmer Medizinsysteme GmbH
    Date Cleared
    2026-01-16

    (108 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    All
    Reference & Predicate Devices
    K240234
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CoolTone device is indicated to be used for:

    • Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen
    • Strengthening, toning and firming of buttocks and thighs

    When intended to stimulate healthy muscles to improve or facilitate muscle performance, CoolTone induces muscle contractions to enhance muscle function and may therefore be considered a technique of muscle training.

    In addition, the CoolTone is indicated to be used for:

    • Relaxation of muscle spasms
    • Prevention or retardation of disuse atrophy
    • Increasing local blood circulation
    • Muscle reeducation
    • Maintaining or increasing the range of motion

    CoolTone may also be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Furthermore, CoolTone device may be used to stimulate neuromuscular tissue for bulk muscle excitation in the legs for rehabilitative purposes.

    Device Description

    The CoolTone system is a non-invasive, therapeutic device. The device produces an electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, CoolTone helps to strengthen, tone and firm the abdomen, buttocks and thighs.

    The device is a mobile standalone unit with four wheels, and the device housing protects the patient from electrical shock and mechanical injury.

    Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. The device is a medical equipment that generates a magnetic field by applying a strong current to an applicator. CoolTone is equipped with a securement system, designed to maintain the position of the applicator throughout treatment.

    A large color touch screen facilitates the use of the device. The on-screen information guides the user, step-by-step, through the entire treatment process. The treatment is operated through variable parameters such as frequency, time and intensity. Three pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.

    AI/ML Overview

    N/A

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