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    K Number
    K022776
    Device Name
    NESS SYSTEM
    Manufacturer
    NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
    Date Cleared
    2002-09-11

    (21 days)

    Product Code
    IPF,IPG
    Regulation Number
    890.5850
    Type
    Special
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K952273,K982482
    Why did this record match?
    Reference Devices :

    K952273, K982482

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

    The NESS System is intended to be used for the following indications:

    • maintenance or increase of range of motion, ●
    • reduction of muscle spasm, ●
    • prevention or retardation of disuse atrophy, .
    • muscle reeducation, and ●
    • increasing local blood circulation. .
    Device Description

    The NESS System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries, serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the thigh, or the leg is provided.
    A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessorcontrolled switching of the stimulation between these electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle.
    The electrode locations allow the NESS System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.

    AI/ML Overview

    The provided text is a 510(k) summary for the NESS System, a powered muscle stimulator. It details the device's intended use, description, and its substantial equivalence to a predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement, as this information is not present in the provided 510(k) submission.

    The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Handmaster NMS1) by stating that the only difference is the provision of additional plastic splints for treating other limb sites. This type of submission generally relies on the predicate device's established safety and effectiveness rather than new performance studies for the minor modification.

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