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510(k) Data Aggregation

    K Number
    K231575
    Device Name
    Vecttor VT-300
    Manufacturer
    Artaflex Inc.
    Date Cleared
    2024-02-08

    (253 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    LIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and or management of post-traumatic or post-surgical pain.
    Device Description
    VT-300 device is portable and battery operated. VT-300 Device is comprised of a PCBA and a lithium-ion battery enclosed in a polycarbonate housing. The device's dimensions are 2.1 inches wide, 3.3 inches long, and 0.75 inch in height. Vecttor VT-300 provides Interferential Current Therapy. Eight electrodes attached to a pair of lead wires are intended to be positioned on the patient's body to deliver four channels of current from VT-300 dual output jacks. Temperature sensors continually monitor finger surface temperatures with the intention of identifying and then applying an Interferential Current Therapy level that results in specified temperature increases. The user controls the VT-300 device using Vecttor Mobile App which is a mobile application downloadable on Bluetooth enabled mobile devices using Android or iOS operating systems from the Google Play or Apple App store. Vecttor Mobile App provides the necessary user interface to establish connection to the VT-300 device via Bluetooth, and operate VT-300 device to provide interferential current therapy.
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    K Number
    K202725
    Device Name
    ETD4000
    Manufacturer
    TheraSigma, LLC
    Date Cleared
    2021-03-26

    (190 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    LIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interferential Current Stimulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
    Device Description
    Not Found
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    K Number
    K183692
    Device Name
    Avid IF2
    Manufacturer
    Vision Quest Industries Inc./ dba VQ OrthoCare
    Date Cleared
    2019-06-12

    (163 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    LIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avid IF2 Interferential Stimulator, Model AV-IF19A is indicated for use in the following applications: - -Symptomatic relief of post-surgical and/or post traumatic acute pain - -Symptomatic relief of chronic intractable pain -Relaxation of muscle spasms -Maintaining and increasing range of motion -Increases local blood circulation
    Device Description
    The Avid IF2, Model AV-IF19A is an Interferential Stimulator that produces a low electrical current that is transmitted via lead wires to electrodes placed on the skin in the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and a keypad.
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    K Number
    K122944
    Device Name
    GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
    Manufacturer
    GEMORE TECHNOLOGY CO., LTD.
    Date Cleared
    2012-12-21

    (88 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    LIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
    Device Description
    The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.
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    K Number
    K121662
    Device Name
    VECTTOR VT-200
    Manufacturer
    ALAN NEUROMEDICAL TECHNOLOGIES LLC
    Date Cleared
    2012-11-21

    (169 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    LIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.
    Device Description
    The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on acupressure points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain. Once these electrodes are placed, the machine determines the appropriate stimulation intensity by automatically measuring body temperatures through the use of two specially designed Thermistors placed on the fingers during a testing sequence. The VT-200 delivers four channels of current from dual output jacks through Treatment Leads and Electrodes which are positioned on the patient's body according to treatment protocols.
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    K Number
    K110509
    Device Name
    EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
    Manufacturer
    EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
    Date Cleared
    2011-06-20

    (118 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    LIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain. It is intended for use on the order of a physician only.
    Device Description
    The Everyway IF-908 Interferential stimulator is the device which generates the small ture-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved The Everyway IF-809 interferential stimulator consists mainly of two parts: the stimulus generator, and electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief The stimulation current is generated in such a way that the frequency in channel 1 is fixed, but frequency in channel 2 is adjustable. Also the output amplitude is also adjustable. Those adjustable parameters could provide user some stimulation output change depending upon the condition of patients according to the prescription of physician. In general IF-908 is the prescribtion device, which needs the physician instruction for stimulation treatment. IF-908 provides two different alternative power supply system. <1> 9V internal battery, <2> 9V rechargeable battery pack charged by adaptor. The operator may recharge 9V battery pack for long term use via the power rechargeable battery system of IF-908. The battery pack can not be charged during operation via using 9V battery pack power.
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    K Number
    K100246
    Device Name
    MAX-IF1000
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2010-11-24

    (301 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    LIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAX-IF1000 interferential stimulator is used for symptomatic relief and management of chronic pain and/or an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
    Device Description
    MAX-IF1000 Interferential Stimulator
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    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?
    Product Code :

    LIH

    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
    K092763
    Device Name
    IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
    Manufacturer
    WELL-LIFE HEALTHCARE LIMITED
    Date Cleared
    2009-10-08

    (29 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    LIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
    Device Description
    The WL-2206D are the device which generates the small true-sine pulses of electrical current. The qenerated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.
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    K Number
    K090023
    Device Name
    IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
    Manufacturer
    WELL-LIFE HEALTHCARE LIMITED
    Date Cleared
    2009-01-30

    (25 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    LIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
    Device Description
    The WL-2206B and WL-2106E are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.
    Ask a Question

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