Delta International Service & Logistics receives FDA 510(k) Clearance for Scrambler Therapy® MC-5A
ROME, June 15, 2015 /PRNewswire/ --
The FDA authorized the marketing of the Scrambler Therapy® Technology MC-5A device. This medical device has been developed in Italy for the treatment of chronic neuropathic and oncologic pain resistant to opiates and other types of treatment, replacing the previous version, known in the US as the Calmare® device.
Scrambler Therapy® Technology MC-5A development in the US
Delta International Service & Logistics' main goal in the US is to create the conditions to fully implement the methodology in line with the original standards which are the only ones to guarantee a meaningful increase of success rates in hospitals and independent clinical trials. In the coming months this enterprise will create a series of excellence centers to guarantee an optimal quality system for ST usage including ST-NET support, a clinical "intelligent" network based on a dedicated software designed exclusively for Scrambler Therapy®. This software informs in real time the operator of possible critical features, and suggests most fit treatment protocols for any patient. In the future some of these centers will be selected for the development of an adequate training and support system to optimize the users' learning curve. These elements are necessary to reduce to a minimum operator dependent bias, that as recorded in statistical data from some independent clinical trials is currently very high, and well beyond the norm.
About Delta International Service & Logistics
DIS&L is an agency created for the international development of Scrambler Therapy® Technology MC-5A, and selecting of medical device distributors in all international area. DIS&L through its law firm is the only company authorized to sign international exclusive agreements, provide maintenance and distributor support for method usage training and other logistics needs.
About Scrambler Therapy® Technology MC-5A
Scrambler Therapy® scientific research and development technology have been developed in Italy by Professor Giuseppe Marineo, who is the sole owner of its intellectual property rights. The official "Scrambler Therapy"® scientific and clinical information website is at http://www.scramblertherapy.org/english.htm). FDA 510(k) Clearance: # K142666, CE Certified: #CE 0470.
Contact U.S. DIS&L Division:
Richard J. Erickson, North America Operations 6419
Hirondel St, Houston, TX 77087,406-249-0424
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