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510(k) Data Aggregation

    K Number
    K161055
    Device Name
    Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15
    Manufacturer
    Fuji Dynamics Ltd
    Date Cleared
    2016-07-12

    (89 days)

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

    Fuji Dynamics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fuji Dynamics Incontinence Stimulation Electrodes are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
    Device Description
    The Fuji Dynamics Incontinence Stimulation Electrode models Fuji-01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 are the light weight cylinder consisting of two or three independent conductive rings or plates that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and handle for comfort positioning in vaginal canal for incontinent treatment and easy in removing after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing and drying between uses.
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    K Number
    K152676
    Device Name
    FD TENS 2090, FD TENS 2095
    Manufacturer
    FUJI DYNAMICS LTD
    Date Cleared
    2016-01-22

    (126 days)

    Product Code
    GZJ, CLA, IPF
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUJI DYNAMICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a TENS device, FD TENS 2090 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. As a EMS device. FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for: - Prevention or retardation of muscle disuse atrophy. - · Relaxation of muscle spasm. - · Muscle re-education. - · Maintaining or increasing range of motion. - · Increasing local blood circulation. - · Immediate post-surgical of calf muscle to prevent venous thrombosis. FD TENS 2095 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    FD TENS 2090 can provide both TENS treatments and EMS treatments. During TENS treatments, the FD TENS 2090 generates electrical pulses and transmit it to the electrodes which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain. During EMS treatments, FD TENS 2090 generates electrical pulses and transmit it to the electrodes attached to the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms. prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, reeducate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis. FD TENS 2095 can provide TENS treatment, During treatment, the FD TENS 2095 generates electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
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    K Number
    K152374
    Device Name
    LL TENS 160A, LL TENS 160B
    Manufacturer
    Fuji Dynamics Ltd
    Date Cleared
    2016-01-13

    (145 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fuji Dynamics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LL TENS 160A and LL TENS 160B are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    LL TENS 160A and LL TENS 160B are handheld battery powered TENS devices for pain relief intended for over-the-counter use. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's (user's) skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain. LL TENS 160A and LL TENS 160B has two output channels and four preset programs. The program mode is displayed on LCD. The user can adjust the output intensity by 14 steps. LL TENS 160A and LL TENS 160B have same hardware, software and mechanical structure. The difference is that LL TENS 160A's LCD display is placed on the bottom of keys while LL TENS 160B's LCD display is on the top of keys. Since the device is battery powered, there is no connection to AC mains supply.
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    K Number
    K111654
    Device Name
    FD TENS 2070
    Manufacturer
    FUJI DYNAMICS LTD
    Date Cleared
    2012-03-01

    (262 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUJI DYNAMICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FD2070 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of chronic post-surgical and post-traumatic acute pain.
    Device Description
    As a Transcutanous Electrical Nerve Stimulator (TENS) unit, FD2070 generates patientical pulses and transmit it to the electrodes, which are attached in the skin to the underlying peripheral pulses would then pass his gold then pass through the unders skin to the underlying peripheral nerves no aid in the pass through the skin to the underlying peripheral nerves to aid in the blocking to the traveling to the brain.
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    K Number
    K111645
    Device Name
    FD TENS 2050 OR SLIDE TENS MODEL FD2050
    Manufacturer
    FUJI DYNAMICS LTD
    Date Cleared
    2011-11-09

    (149 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUJI DYNAMICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FD2050 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    The FD2050 is a handheld battery powered TENS device. which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain. FD2050 has two output channels and five preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 20 steps.
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