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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMSI, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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).
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