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510(k) Data Aggregation

    K Number
    K002889
    Device Name
    PNS MAGNETIC STIMULATOR SYSTEM
    Manufacturer
    NEOTONUS, INC.
    Date Cleared
    2001-04-06

    (203 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOTONUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001903
    Device Name
    NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
    Manufacturer
    NEOTONUS, INC.
    Date Cleared
    2000-08-29

    (68 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOTONUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K973096
    Device Name
    NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
    Manufacturer
    NEOTONUS, INC.
    Date Cleared
    1998-06-12

    (297 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOTONUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NEOTONUS Model 1000 Muscle Stimulator System is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.
    Device Description
    The Model 1000 Muscle Stimulator System consists of a stimulator control unit and a treatment chair. The stimulator control unit is used to generate a voltage signal that periodically charges an "E" shaped magnetic coil located beneath the seat of the treatment chair. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-cycle "Rest" period (0-60 sec). During treatment, the patient sits on the treatment chair with the pelvic floor area centered over the magnetic coil. The magnetic field emitted by the coil induces an electric field in the target tissue that causes contraction of the pelvic floor musculature. The patient is treated fully clothed and there is no need for an invasive electrode probe. Treatment is suggested as up to 30 minutes per sessions separated by at least 2 days.
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    K Number
    K973929
    Device Name
    NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
    Manufacturer
    NEOTONUS, INC.
    Date Cleared
    1998-05-21

    (218 days)

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

    NEOTONUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The Neotonus MS-101 is indicated for use in stimulating neuromuscular tissues for bulk muscle excitation in the legs or arms for rehabilitative purposes. Indications for Use for Muscle Stimulators: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of call muscles to prevent venous thrombosis - Maintaining or increasing range of motion
    Device Description
    The MS-101 Magnetic Muscle Stimulator System consists of a stimulator Control Unit and a Treatment Wand. The Control Unit is used to generate a voltage signal that periodically charges a "C" shaped magnetic coil which is held against the patient's skin nearest the muscle group to be stimulated. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-duty "Rest" period (0-60 sec).
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