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510(k) Data Aggregation

    K Number
    K092780
    Device Name
    INF 4160 PLUS, MODEL D-FJ31F
    Manufacturer
    FUJI DYNAMICS LIMITED
    Date Cleared
    2010-01-07

    (119 days)

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

    FUJI DYNAMICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INF 4160 PLUS 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
    INF 4160 PLUS is an Interferential Current Therapy Device. It generates a set of symmetric sinusoidal electrical signals which are delivered to the user or patient through lead cables to the electrode pads placed on the skin. The electric signals stimulate the nerves underneath. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
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    K Number
    K063642
    Device Name
    FD EMS, MODEL # D-FJ30E
    Manufacturer
    FUJI DYNAMICS LIMITED
    Date Cleared
    2007-12-13

    (371 days)

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

    FUJI DYNAMICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FD EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following: - Prevention or retardation of muscle disuse atrophy; - - Relaxation of muscle spasm; . - Muscle reeducation; ・ - Maintaining and increasing the range of motion; - - Increasing local blood circulation; - - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. .
    Device Description
    The FD EMS is a handheld battery powered EMS device, which is used for muscle stimulation. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the skin of patient. Consequently, the electrical pulses would then pass through the skin to nerves of the muscle and cause the muscle to expand and contract. FD EMS has two output channels and seven stimulation programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 15 steps.
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    K Number
    K052813
    Device Name
    FD TENS 2030, MODEL DFJ24T
    Manufacturer
    FUJI DYNAMICS LIMITED
    Date Cleared
    2006-01-25

    (113 days)

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

    FUJI DYNAMICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FD TENS 2030 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 FD TENS 2030 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. FD TENS 2030 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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    K Number
    K043407
    Device Name
    INF 4160, MODEL D-FJ27F
    Manufacturer
    FUJI DYNAMICS LIMITED
    Date Cleared
    2005-02-11

    (63 days)

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

    FUJI DYNAMICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INF 4160 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 INF 4160 is a rechargeable battery operated Interferential Current Therapy Device. Its internal circuitry can generate symmetrical sinusoidal waveforms. The associated outputs are delivered through lead cables to electrodes placed on the user/patient skin. The output passes through the skin and activates the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
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    K Number
    K041164
    Device Name
    L-TENS
    Manufacturer
    FUJI DYNAMICS LIMITED
    Date Cleared
    2004-05-20

    (17 days)

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

    FUJI DYNAMICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The L-TENS 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 L-TENS 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. L-TENS has one output channel and four preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 14 steps.
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    K Number
    K994265
    Device Name
    MEDISANA DIGITAL TENS
    Manufacturer
    FUJI DYNAMICS LIMITED
    Date Cleared
    2000-07-06

    (202 days)

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

    FUJI DYNAMICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drugfree pain management unit. The TENS system is designed for the treatment of pain > chronic, acute or post-operative pain.
    Device Description
    Not Found
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    K Number
    K994266
    Device Name
    FDTENS 2010
    Manufacturer
    FUJI DYNAMICS LIMITED
    Date Cleared
    2000-07-06

    (202 days)

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

    FUJI DYNAMICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drugfree pain management unit. The TENS system is designed for the treatment of pain - chronic, acute or post-operative pain.
    Device Description
    Not Found
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