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510(k) Data Aggregation

    K Number
    K192249
    Device Name
    InMode System with Tone Applicator
    Manufacturer
    InMode Ltd.
    Date Cleared
    2019-12-17

    (120 days)

    Product Code
    IPF,GZJ
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K132284
    Why did this record match?
    Device Name :

    InMode System with Tone Applicator

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

    The InMode System with Tone Applicator is used in EMS mode for:
    Prevention or retardation of disuse atrophy
    Maintaining or increasing range of motion
    Muscle re-education
    Relaxation of muscle spasms
    Increasing local blood circulation
    Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

    And in TENS mode for: Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

    Device Description

    The InMode System in combination with Tone Applicator (manufactured by InMode Ltd.), is a versatile device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications. The InMode System with Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the front panel.

    AI/ML Overview

    This document describes the InMode System with Tone Applicator, a powered muscle stimulator. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device (Vectra Neo Clinical Therapy System, K132284), rather than presenting a standalone study with acceptance criteria for device performance in the clinical sense (e.g., sensitivity, specificity for a diagnostic device).

    Therefore, this response will reframe the "acceptance criteria" as the performance standards and safety criteria the device was tested against for regulatory clearance. The "study that proves the device meets the acceptance criteria" refers to the non-clinical (bench) performance data and compliance with recognized standards.

    1. A table of acceptance criteria and the reported device performance

    Since this is a submission for a powered muscle stimulator, the "acceptance criteria" revolve around demonstrating safety, electrical performance, and biocompatibility, as well as functional equivalence to the predicate device. The "reported device performance" are the results of the non-clinical tests and conformance to standards.

    Acceptance Criteria (Performance/Safety Standard)Reported Device Performance
    Electrical Safety & Essential Performance
    IEC 60601-1 (General Requirements for Basic Safety and Essential Performance)Device complies with the standard. Specific safety parameters: Patient Leakage Current - Normal Condition (
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