Scrambler Therapy® Device Generations
An overview of the engineering evolution and clinical refinement of Scrambler Therapy technology.
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2021 - Present (Gen III)
Scrambler Therapy® Technology ST-5A
ST-5A
The Scrambler Therapy® ST-5A is the current OEM generation of the technology and the only Scrambler Therapy® device presently in production and manufacturer-supported. Since 2021, production has been centralized in Italy to enhance quality control, ensure regulatory alignment with evolving international medical device standards, and strengthen long-term manufacturing oversight. This transition replaced the prior MC-5A model and reflects a focused effort to optimize engineering reliability and compliance.
The ST-5A incorporates refinements to mechanical design, connectors, electromagnetic compatibility (EMC), and quality control systems, along with expanded 110–120V power compatibility to support global clinical deployment. All indexed, peer-reviewed scientific literature evaluating Scrambler Therapy is based on this core technology platform, which has been studied in severe chronic pain populations, including opioid-resistant, neuropathic, and oncologic pain conditions.
Only OEM-manufactured, supported, and authorized Scrambler Therapy® device currently offered for sale
Design and manufacturing enhancements implemented to ensure long-term reliability and quality control
The technology platform underlying the peer-reviewed clinical literature supporting Scrambler Therapy
2014 - 2019 (Gen II)
MC-5A (Gen II)
Scrambler Therapy® Technology MC-5A (Gen II)
The MC-5A, Generation 2, represents the second OEM-produced version of Scrambler Therapy®, manufactured between 2014 and 2019. While externally similar to the original generation, this version incorporated meaningful internal electrical refinements, particularly within the artificial neuron core support system, resulting in improved reliability and overall device performance. These upgrades strengthened operational stability while maintaining the established treatment platform.
This generation was recognized under FDA 510(k) clearance K142666 and CE marking 0476. Production was discontinued in 2020 and the device is no longer commercially available for purchase.
Second OEM-produced generation with significant internal reliability upgrades over first generation MC-5A
Recognized under FDA 510(k) clearance K142666 and CE marking 0476
Production discontinued in 2020 and no longer commercially available
2008 - 2013 (Gen I - "Calmare")
Scrambler Therapy® Technology MC-5A (Gen I) - "Calmare"
MC-5A (Gen I) - "Calmare"
Generation 1 represents the first industrialized OEM version of the Scrambler Therapy® device, manufactured beginning in 2008. This version incorporated the original hardware and software architecture of the artificial neuron core technology used in early clinical development. In certain markets, the device was also distributed under the alternative trade name “Calmare,” sometimes reflected on the device labeling.
This generation was recognized under FDA 510(k) clearance K081255 and CE marking 0470. Production was discontinued in 2013 and has not resumed. This device is no longer authorized for commercial sale or distribution.
First industrialized OEM version of Scrambler Therapy®, manufactured from 2008–2013
Recognized under FDA 510(k) clearance K081255 and CE marking 0470
Production discontinued in 2013 and not authorized for current commercial sale
Prototype
ST5
Scrambler Therapy® ST5
The ST-5 prototype represents the early clinical development platform of Scrambler Therapy®, used in Italy prior to 2007. This prototype incorporated the foundational artificial neuron software core and early ST stable technology architecture that informed subsequent OEM generations.
The device was utilized in approximately 2,297 documented clinical cases involving severe neuropathic pain resistant to pharmacologic and conventional electro-analgesic treatments.
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Last updated on February 26, 2026
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Scrambler Therapy® is intended for the non-invasive treatment of chronic neuropathic pain through transcutaneous electrical stimulation designed to provide symptomatic relief of pain. Scrambler Therapy® should only be administered by individuals who have completed authorized Scrambler Therapy® training and certification, and its use should be guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of indications, contraindications, warnings, and precautions.
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