Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K153559
    Device Name
    OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
    Manufacturer
    Accelerated Care Plus (ACP)
    Date Cleared
    2016-08-26

    (256 days)

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

    Accelerated Care Plus (ACP)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OmniVersa™ Multi Modality Therapy and Omnistim® FX2 Professional Therapy Systems by ACP use the Omnistim® FX2 Stimulator for the following indications for use: - · Relaxation of muscle spasms - · Re-education of muscle - · Prevention or retardation of disuse atrophy - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Increases local circulation - · Maintains or increases range of motion Stimulator waveforms: IFC, LVPC, and VMS: · Symptomatic relief and management of chronic intractable pain and as an adjunctive treatment of acute pain, post-surgical pain and pain associated with post-traumatic injury. Electrical muscle stimulator devices should be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The OmniVersa™ Multi-Modality Therapy System also uses Omnisound® Ultrasound Transducer(s) for the following indications for use: - Relieves pain - · Decreases joint stiffness and contractures - · Reduction of muscle spasm - · Increases local circulation - · Relief of pain, muscle spasms, and joint contractures that may be associated with: adhesive capsultiis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues - · Relief of sub-chronic, chronic pain and joint contractures resular tightness, capsular scaring
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1