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510(k) Data Aggregation

    K Number
    K203525
    Device Name
    D function
    Manufacturer
    ITO CO., LTD.
    Date Cleared
    2021-05-05

    (155 days)

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

    ITO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain 2) Muscle re-education 3) Increasing blood flow 4) Maintain or increase mandibular range of motion
    Device Description
    This device is a current stimulation device with Therapeutic Electro Muscle Stimulator function. Power is supplied by the built-in rechargeable lithium batter. The stimulation current generated by the output circuit of the main body is supplied to the user through the electrode to realize current stimulation. The device is equipped with PAIN mode and MCR mode. Each CH can output independently and be adjusted. If it outputs in CARE mode, it can be used for both outputs at the same time.
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    K Number
    K112520
    Device Name
    US-101L, US-103S
    Manufacturer
    ITO CO., LTD.
    Date Cleared
    2011-10-26

    (56 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The US-101L, US-103S are indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
    Device Description
    US-101L, US-103S are portable type ultrasound therapy units with built in ultrasound transducer. Ultrasound head (probe) is integral with the main body. Two sizes, US-101L (L size) for 1MHz and US-103S (S size) for 3MHz are available. In the output mode, continuous output (100%) or pulsed output (50%, 40%, 20%, 10%, 5%) are used. These units are intended to treat the affected area by applying the treatment head to skin.
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    K Number
    K081943
    Device Name
    MODEL ES-130
    Manufacturer
    ITO CO., LTD.
    Date Cleared
    2008-11-24

    (139 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the ES-130 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    ES-130 is a palm-size ELECTRO-ACUPUNCTURE DEVICE equipped with three independent output channels. This unit has incorporated similar features as the predicate devices such as: Variable Frequency Settings & Similar Frequency Range, Variable Intensity Settings & Similar Output Range, Biphasic Pulse Waveform, Similar Pulse Shape & Pulse Charge, Battery Power & Portability.
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    K Number
    K081247
    Device Name
    TM-400
    Manufacturer
    ITO CO., LTD.
    Date Cleared
    2008-08-25

    (116 days)

    Product Code
    ITH
    Regulation Number
    890.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the TM-400 powered traction device is indicated for the following: - Providing standard therapeutic and custom user-defined treatments in static, intermittent, . progressive, regressive, cyclical and combination distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). - Providing traction and mobilization of skeletal structures and skeletal muscles. . - . Relieving peripheral radiation / sciatica and pain associated with: Discs: - A Protruding, bulging, herniated and prolapsed discs - A Degenerative disc disease - A Discogenic pain Facets: - A Facet syndrome - A Posterior facet syndrome - Acute facet problem A Muscles & Joints: - Muscle pain and spasms A - Degenerative joint disease A Spinal Structures: - Spinal root impingement A - a Pinched nerves - A Compression fractures ## Pain: - Back, lower back, neck, joint, sciatic and radicular pain A Mobility & Flexibility: - > Hypomobility - > Limited spinal and joint flexibility
    Device Description
    The TM-400 is a simple to use powered traction unit that offers static, intermittent, and cycle traction with user-definable hold, rest and treatment times. The unit consists of a software-controlled electro-mechanical traction system. The physical characteristics of the TM-400 are substantially equivalent to the predicate traction devices including size, weight, materials of construction, and user interface. In addition, the unit has incorporated similar features as the predicate devices such as: - ア Automatic calibration of traction force - > An internal memory that stores up to 30 treatment patterns - A Traction speed selectable from five preset values - 公 Eight traction modes - A Remote patient-controlled treatment shutoff switch - ﺮ Large and high-visibility LCD screen The TM-400 traction device operates by attaching the cable hook to a harness accessory, which is in turn attached to the patient treatment area, for traction and mobilization of skeletal muscles according to the detailed indications of use.
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    K Number
    K032793
    Device Name
    US-100 PORTABLE ULTRASOUND THERAPY UNIT
    Manufacturer
    ITO CO., LTD.
    Date Cleared
    2003-10-09

    (30 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The US-100 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
    Device Description
    The US-100 Ultrasound Therapy Unit consists of a main unit and two applicators. The device may be operated in continuous or pulsed modes. The US-100 has an output power of 8 W and operates at 0.8 MHz. It is supplied with one applicator, and another smaller applicator is available as an option. The device has an LCD screen that serves as the interface with the user to specify options, provide messages, and display parameters.
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    K Number
    K024342
    Device Name
    RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
    Manufacturer
    DAITO CO., LTD.
    Date Cleared
    2003-04-23

    (117 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAITO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Developing exposed x-ray film.
    Device Description
    Designed solely for processing of radiographed films, by roller transport system and by use of developer/fixer solutions(that are to be locally obtained).
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    K Number
    K022846
    Device Name
    SW-180 SHORTWAVE THERAPY UNIT
    Manufacturer
    ITO CO., LTD.
    Date Cleared
    2003-01-28

    (154 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SW-180 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
    Device Description
    The SW-180 Shortwave Therapy Unit consists of a main unit and a standard applicator. Several other types of applicators are available as options. The device may be operated in continuous or pulsed modes. The SW-180 has an output power of 80 W and operates at 27.12 ± .16 MHz. The device has an LED screen that serves as the interface with the user to specify options, provide messages, and display parameters. The SW-180 Shortwave Therapy Unit device is a prescription device and the prescription statement is contained in the labeling as required.
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    K Number
    K990787
    Device Name
    TRIO 300
    Manufacturer
    ITO CO., LTD.
    Date Cleared
    1999-10-20

    (224 days)

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

    ITO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TENS and Microcurrent modes of the Trio 300 are indicated for the symptomatic relief of chronic intractable pain. They are also indicated for the treatment of post-traumatic and post-surgical pain. The electrical muscle stimulation (EMS) mode is indicated for relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
    Device Description
    The Trio 300 Multi-Mode Electrical Stimulator is a small, portable, battery-powered electrical stimulator device that has four stimulation modes, (1) TENS, (2) EMS, (3) microcurrent, and (4) programmable. The device has an LED screen that serves as the interface with the user to specify options, provide messages, and display parameters. The device is supplied with an AC adaptor for line current operation. The Trio 300 consists of the pulse generator, A/C power adapter, and the surface electrodes. The Trio 300 is a dual-channel electrical stimulator with four output modes. The device is equipped with a liquid crystal display (LCD) for communication with the user. The SELECT key allows the user to scroll through the options (e.g., mode) available at a particular point and the SET key allows the selection of the displayed option. The UP-ARROW and DOWN-ARROW keys allow the user to increase or decrease certain selected parameters.
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    K Number
    K992545
    Device Name
    TM-300 TRACTION SYSTEM
    Manufacturer
    ITO CO., LTD.
    Date Cleared
    1999-09-01

    (33 days)

    Product Code
    ITH, HST
    Regulation Number
    890.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TM-300 Traction System is indicated for relief of pain in cases of low back pain. Each treatment consists of a physician-prescribed session designed to provide static, intermittent, or cycling distraction forces to relieve pressure on structures that may be causing low back pain. The TM-300 relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
    Device Description
    The TM-300 Traction System is an automatic intermittent traction system for traction therapy. The patient always holds a safety switch that can interrupt treatment if it becomes uncomfortable. Several "mechanical waveforms" are available for selection by the operator, including: (1) Basic intermittent traction, (2) Incremental intermittent traction, (3) Incremental and decremental intermittent traction, (4) Residual intermittent traction, (5) Incremental and residual intermittent traction, (6) Incremental, decremental and residual intermittent traction, (7) Basic continuous traction, (8) Incremental continuous traction. The residual tractive force, the duration time setting, the pause time setting, the tow speed, and the treatment time setting are all programmable up to specified limits. For forces selected above 18 kg, the system always asks for confirmation of the selected value by the operator before proceeding. A limit switch prohibits output exceeding 100 kg.
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