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510(k) Data Aggregation

    K Number
    K233926
    Device Name
    accufit
    Manufacturer
    Mettler Electronics Corporation
    Date Cleared
    2024-03-21

    (99 days)

    Product Code
    IPF, NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mettler Electronics Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The accufit is indicated for use for Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen, and Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
    Device Description
    The principle of operation of the accufit device is to provide direct electrical stimulation of muscles which produces muscle contractions in and around the area of the treatment electrodes. The accufit generates electrical stimulation to contract the muscles to achieve the desired intended use using unique IntelliPhase waveforms and IntelliSTIM electrodes. It offers two unique IntelliPhase waveforms, Biphasic and Interferential (4P), that are designed to optimize muscle re-education and activation for patients. The four IntelliPhase waveform protocols are twist, hold, grip, and tap. Each protocol may be used for 15, 30, or 45 minutes. Not only are there four IntelliPhase protocols, but there is also a fully automated protocol (IntelliCycle) that integrates all the above listed waveforms in a comprehensive, interlaced series. This engages all the targeted muscles in a continuous program to maximize muscle effects with the touch of a button. accufit is both the proprietary-trade name and generic name. accufit is a supplement to existing treatments and does not replace any traditional treatment or therapy. The system console is the heart of the accufit and contains the Touch LCD/GUI, electrodes, and power supply module. The main console also includes a key switch used to turn the power on and off, and an emergency stop push button that quickly de-energizes the system in emergency situations. There are 4 casters in the console base that can be used when moving the system.
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    K Number
    K223802
    Device Name
    accufit
    Manufacturer
    Mettler Electronics Corporation
    Date Cleared
    2023-10-06

    (291 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mettler Electronics Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increase local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
    Device Description
    accufit (subject device) when using the Biphasic/Interferential (4P) waveforms is a noninvasive powered muscle stimulator used to provide an electrical stimulation of muscles for muscle re-education. The accufit is used on an outpatient basis under the supervision of a clinician. The accufit is the result of a close collaboration between Lutronic Corporation and Mettler Electronics, Corporation. Mettler is the manufacturer of both the subject and predicate device. Using the Mettler Sys*Stim ME240 (K113017) as a starting point, the accufit utilizes two of the original and unchanged waveforms for muscle reeducation. There are four preprogrammed treatment regimens that enable users to mimic common physical exercises. Each treatment regimen has recommended treatment electrode placement depicted in both the accufit operator's manual and on the accufit graphic user interface (GU). The IntelliSTIM treatment electrodes have been designed to support the accufit and are controlled by an intelligent real-time impedance feedback Mettler System. The IntelliSTIM are held in place with hydrogel adhesive strips and Velcro body wraps. The user may select the treatment duration of either 15, 30 or 45 minutes. The size, type of electrode and technical/performance characteristics.
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