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Scrambler Therapy® – The Medical Device Generations

A Scrambler Therapy ® device is always characterized by the same hardware and software OEM core of artificial neurons, and by the presence of 5 channels, an indispensable condition to maintain the same safety and efficacy performance validated by numerous official clinical studies and thousands of cases of chronic neuropathic and cancer pain.
In view of these specific approach, it is quite clear that the concept of similarity that only considers the parameters of frequency, pulse width and intensity (used in other devices) for this Technology is not applicable because they do not generate and do not characterize the specific information of “no pain” of the Scrambler Therapy®.
In this sense any modification of the emissions of the Scrambler Therapy in the form and organization of the flows in time (i.e. the specific strings of "no pain" information), is functionally equivalent to the modification of the chemical formula of a drug.

Scrambler Therapy ® Technology ST-5A

Last OEM version of the Scrambler Therapy® Technology device. In production since 2021 (full made in Italy). To comply the new European Medical Devices Regulation we decided to transfer the device production from Korea (previous generations MC-5A) to Italy. On this occasion the new device was improved in many parts such as mechanics, design, connectors, EMC, quality control. The power supply system now also accepts 110-120V. The new Scrambler Therapy® ST-5A device replace previous model MC-5A.

This new OEM version It is currently the only Scrambler Therapy® device in production. International distribution (including in the U.S.) is entrusted exclusively to Delta International Services & Logistics.

Scrambler Therapy® Technology MC-5A

It is the second OEM version of the device (2014-2019). Aesthetically there are no variations with the previous version, but the OEM artificial neuron core support technology external has undergone significant improvements in its reliability.

This second OEM version is recognizable by the 510 (k) # K142666 and CE marking 0476. This device production was interrupted in 2020.

Scrambler Therapy ® MC-5A “Calmare”

First industrialized OEM version (the hardware and software project core of artificial neurons used in clinical trials cannot be modified) known in the U.S. also with the alternative trade name of "Calmare", sometimes also present on the device with a self-adhesive label.

This device was manufactured in 2008 recognizable by the 510 (k) # K081255 and the CE 0470 marking. This device production was interrupted in 2013.

Scrambler Therapy ® ST5

Prototype used for clinical studies in Italy (2297 cases of various types of serious neuropathic pain that was resistant to medications and/or electro-analgesia) until 2007. Software core of artificial neurons and the ST stable technology.

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