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510(k) Data Aggregation

    K Number
    K040121
    Device Name
    DERMAWAVE 5000 COMBI MAX SYSTEM
    Manufacturer
    Date Cleared
    2004-03-17

    (57 days)

    Product Code
    Regulation Number
    890.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMAWAVE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Stimulation, relaxing, and/or repeatedly contracting muscles by passing electrical currents through electrodes contacting the affected body area in the medical specialties of physical medicine, general and plastic surgery and neurology and/or for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms and joint contractures in the medical specialty of physical medicine. The indications of the DermaWave 5000 Combi Max System also include the treatment and relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, immediate postsurgical stimulation of calf rnuscles to prevent venous thrombosis, symptomatic relief of chronic intractable pain, management of pain associated with post-traumatic or post-operative conditions using electrical stimulation and are indicated for the application of therapeutic deep heat for the treatment of selected medical conditions such as relief of pain, muscle spasms and joint contractures, relief of pain muscle spasms and joint contractures that may be associated with adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissucs, relief of chronic and sub-chronic pain and joint contractures resulting from capsular tightness and capsular scarring using ultrasound. The DermaWave 5000 Combi Max System is also indicated for use in providing topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
    Device Description
    The DermaWave 5000 Combi Max System is comprised of the following main components: - A system console including software and control electronics. . - A control and display panel. . - · Delivery device accessories including patient cables and electrodes, ultrasound cables, soundheads, and infrared heating accessories.
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