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510(k) Data Aggregation

    K Number
    K150742
    Device Name
    Muscle Stimulation System 110
    Date Cleared
    2015-07-23

    (122 days)

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

    NIVEUS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Niveus Medical Muscle Stimulation System 110 is indicated for: - 1) Maintaining or increasing range of motion of the knee joint - 2) Prevention or retardation of disuse atrophy in the quadriceps - 3) Muscle re-education of the quadriceps - 4) Relaxation of muscle spasms - 5) Increasing local blood circulation
    Device Description
    The Muscle Stimulation System 110 is a portable, externally-powered device which provides electrical stimulation to the quadriceps using constant current pulses. Pulses are delivered via six independently controlled stimulation channels (3 per leg) and are provided to the patient via electrodes integrated into soft Stimulation Array Pads. An Interconnect Cable allows for communication between the System Controller and Stimulation Array Pads. The major components of the system consist of a Controller, an Interconnect Cable, a pair of disposable Stimulation Array Pads configured for application to the quadriceps of a patient, a Power Cord, and Instructions for Use. An optional accessory to the system is the Niveus Medical StayCool FlexPaks.
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    K Number
    K123642
    Device Name
    MUSCLE STIMULATION SYSTEM
    Date Cleared
    2013-03-29

    (123 days)

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

    NIVEUS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Muscle Stimulation System 110 is indicated for: - Maintaining or increasing range of motion of the knee joint - Prevention or retardation of disuse atrophy in the quadriceps - Muscle re-education of the quadriceps - Relaxation of muscle spasms - Increasing local blood circulation
    Device Description
    The Muscle Stimulation System 110 is a portable, externallypowered device which provides electrical stimulation to the quadriceps using constant current pulses. The device is a Powered Muscle Stimulator per 21 CFR § 890.5850 (Product Code: IPF). Pulses are delivered via six independently controlled stimulation channels (3 per leg) and are provided to the patient via electrodes integrated into disposable Stimulation Array Pads. An Interconnect Cable allows for communication between the System Controller and Stimulation Array Pads. The major components of the system consist of a Controller, an Interconnect Cable, a pair of disposable Stimulation Array Pads configured for application to the quadriceps of a patient, a Power Cord, and instructions for use.
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