The Medical Device Generations - Frequently asked questions

Are there different versions of the Scrambler Therapy device?

A: No, there is only one version of the device built under exclusive license in Italy (see the history of the different generations available below).

Q: Is it possible to make a device with the same clinical efficacy and safety characteristics as Scrambler Therapy using a different technology?

A: No, the efficacy and safety characteristics are inextricably linked to the specific hardware and software of the device built under license. Any variation of the original technology would produce unforeseen effects in the nervous system, potentially dangerous, especially in severe forms of pain such as CRPS.

Q: Is the Scrambler Therapy device manufactured in other countries besides Italy?

A: No, the device is produced only in Italy. Previous generations (MC-5A) were temporarily manufactured in Korea (GEOMC), but without patent assignment and without the manufacturer being able to change the original technology. It is clarified that GEOMC has never had the source code of the algorithm, or other confidential information, available. Furthermore, GEOMC never participated in any way in the development of the technology, nor did Prof., Marineo, the inventor of this therapy and its technology, ever participate in other GEOMC projects.

Scrambler Therapy® Technology 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. Considering this 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 (fully made in Italy). To optimize product quality and comply in advance with the constantly evolving international requirements for medical devices, production was moved 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, and quality control. The power supply system now also accepts 110-120V. The new Scrambler Therapy® ST-5A device replaces the previous model, MC-5A, and it is the only Scrambler Therapy® device on the market.

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”

The first industrialized OEM version (the hardware and software project core of artificial neurons used in clinical trials cannot be modified). This first version is also known in the U.S. with the alternative trade name of “Calmare” (sometimes 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

The prototype was used for clinical studies in Italy (2297 cases of various types of serious neuropathic and oncological pain that were resistant to medications and/or electro-analgesia) until 2007. The software and hardware core of the artificial neurons has been made stable and will be used in subsequent industrialized versions.