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510(k) Data Aggregation

    K Number
    K121305
    Device Name
    STERLING MEDICAL IMPULSE 3 STIMULATOR
    Date Cleared
    2012-09-25

    (147 days)

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

    ARMSTRONG INDUSTRIES, INC. DHA MEDIQUIP INT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Interferential Stimulation (INF) is used for symptomatic relief and management of chronic (Iongterm) intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain. External electrical neuromuscular stimulation (NMES) using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of caff muscles to prevent venous thrombosis. Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
    Device Description
    The Impulse 3 is a portable two channel, battery operated combination electrical neuromuscular stimulator (NMES), interferential stimulator (INF), and transcutaneous electrical nerve stimulator (TENS) unit for pain control, and muscle stimulation. This device, supporting symmetric biphasic, pulsed sine, and asymmetrical biphasic waveforms can be used with the preprogrammed protocols or can be manually configured. A graphical display is provided to provide the user a verbose interface to assist in programming the configurable protocols. The device is supplied with electrodes and electrode leads, non-replaceable batteries, wall adapter, instruction manual, and carrying case.
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    K Number
    K970847
    Device Name
    IMPULSE HVG
    Date Cleared
    1997-09-10

    (187 days)

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

    ARMSTRONG INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Impulse HVG Stimulator can be used to treat and provide therapeutic relief for the following indications: - relaxation of muscle spasm - prevention or retardation of disuse atrophy - increasing local blood circulation, and - maintaining or increasing range of motion The Impulse HVG has the same intended medical uses as the listed predicate device (PGS 3000).
    Device Description
    Impulse HVG
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    K Number
    K953982
    Device Name
    SIMPLEX TENS
    Date Cleared
    1997-04-25

    (611 days)

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

    ARMSTRONG INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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