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510(k) Data Aggregation

    K Number
    K221958
    Device Name
    Flex-MI
    Manufacturer
    EMSI, Inc.
    Date Cleared
    2022-10-21

    (108 days)

    Product Code
    IPF,LIH
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K140467,K071869,K112348
    Why did this record match?
    Reference Devices :

    K140467, K071869

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

    Interferential Stimulation

    • Symptomatic relief of chronic intractable pain

    • Adjunctive treatment for the management of post-traumatic or post-surgical pain

    EMS (Electrical Muscle Stimulation)

    • Relaxation of muscle spasm

    • Increasing local blood circulation

    • Muscle re-education

    • Prevention or retardation of disuse atrophy

    • Prevention of venous thrombosis of the calf muscles immediately after surgery

    • Maintaining or increase range of motion

    Device Description

    The Flex-MI is a combination EMS and interferential stimulation device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 4.8V Ni- MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours. Flex-MI is compatible and recommended for use with Everlife self-adhesive electrodes (K012463).

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the Flex-MI device, which is a combination EMS and interferential stimulator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a standalone study with acceptance criteria.

    Therefore, the document does not contain the acceptance criteria and the study details as requested in the prompt. This type of FDA submission (510(k)) primarily aims to show that a new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and indications for use, rather than presenting a full efficacy or performance study against pre-defined acceptance criteria for a novel AI device.

    Without specific acceptance criteria and a detailed study report, it's not possible to populate the requested tables and information. The document explicitly states: "Clinical Data: Clinical data is not required to support the substantial equivalence to the predicate devices." This further confirms that a study to prove performance against acceptance criteria was not part of this submission.

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