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510(k) Data Aggregation

    K Number
    K061516
    Device Name
    STAODYN MAX PRESET, MODEL 4470
    Manufacturer
    COMPEX TECHNOLOGIES, INC.
    Date Cleared
    2007-02-06

    (250 days)

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

    COMPEX TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
    Device Description
    The Staodyn® Max Preset is a Transcutaneous Electrical Nerve Stimulator (TENS) that transmits small electrical pulses through the skin to the underlying peripheral nerves. It is battery operated using 3-AAA batteries and includes two controllable output channels. It generates and delivers electrical impulses whose duration, rate and modulation can be altered by selection of 24 preset programs. The amplitude of the impulses can be increased or decreased with the use of two intensity toggle buttons, one for each output channel. The device has an on/off button that enables the device to be turned on off. In addition, the on/off button can be used to pause a treatment program during use. The stimulator is housed in a molded portable plastic case with a viewable LCD display, accessible keypad, and accessible battery storage compartment.
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    K Number
    K050046
    Device Name
    REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
    Manufacturer
    COMPEX TECHNOLOGIES, INC.
    Date Cleared
    2005-04-13

    (93 days)

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

    COMPEX TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interferential stimulation can be used for the following applications: - Relieve acute pain . - . Relieve and manage chronic pain - Relax muscle spasms . - Maintain and increase the range of motion . - Increase local blood circulation . Neuromuscular stimulation can be used for the following applications: - Relax muscle spasms . - Prevent or retard disuse atrophy . - Increase local blood circulation . - Re-educate muscles . - Maintain or increase the range of motion . - Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles Pulsed direct current stimulation can be used for the following applications: - Reduction of edema (under negative electrode) t - Reduction of muscle spasm . - Influencing local blood circulation (under negative electrode) . - Retardation or prevention of disuse atrophy . - Facilitation of voluntary motor function . - Maintenance or increase of range of motion . Interferential and Neuromuscular combination stimulation can be used for the following applications: - Reduction of edema (under negative electrode) . - Reduction of muscle spasm .
    Device Description
    The IF 3 Wave is a non-invasive medium/low frequency interferential muscle rie it -> wave is a intended for treating patients that have acute and chronic pain, edema, tight musculature, muscle spasms and muscular weakness due to disuse atrophy. The IF 3 Wave stimulator is a microprocessor controlled dual channel Interferential electro-stimulator with neuro-muscular and pulse direct current micronital expabilities. It will offer 4 separate electro-therapy stimulation modalities. Stimulation capacificies: 17 Will on P), neuromuscular electrical stimulation (NMES), r neso direct current (PDC) electrical stimulation, and a combination of interferential and neuromuscular electrical stimulation (IF/NMES). The IF 3 Wave will be capable of storing device settings, use, and compliance data for up to 90 days. It will be capable of down loading the above compliance date through a up to 90 days. which is contained within the battery charger base. Once per phone mic modelin, will be instructed to download the stored data from their device, month, the patient will over compliance report which is forwarded to their physicians for which will ereate a paysician will review the report and provide adjustment to the patient treatment regimen and device setting accordingly. Accessories provided with the IF 3 Wave include lead wires, electrode pads, Accessories proTracu wik, battery charger/modem, phone cable, power supply, and a users manual.
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