DEVICE: Scrambler Therapy® Technology ST-5A (08055205950010)

Device Identifier (DI) Information

Scrambler Therapy® Technology ST-5A
ST-5A
In Commercial Distribution

DELTA INTERNATIONAL SERVICES & LOGISTICS SRL
08055205950010
GS1

1
339950851 *Terms of Use
The Scrambler Therapy® Technology ST-5A is a patented non-invasive electro-analgesia device, with 5 channels that deliver low-intensity stimuli (max. 5 mA) generated by a completely automated treatment program. Five artificial neurons create "packets" (strings) of information recognized as "non pain", the content of which is controlled by a proprietary algorithm. This various information of "no pain" produces an immediate analgesic effect, capable of completely eliminating pain in real time. Up to 5 pairs of independent electrodes can be placed on the patient's body based on the need of the treatment. If the treatment is performed correctly, normally the pain is zeroed (or reduced very close to zero) in real time regardless of the initial intensity and the pathology that generated it. In this technology the concept of similarity that only considers the parameters of frequency, pulse width and intensity (used in other devices) 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, is functionally equivalent to the modification of the chemical formula of a drug. Indications of use - Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain. - Symptomatic relief of acute pain. - Symptomatic relief of post-operative pain. Indications of use that derive from the scientific literature indexed and published in peer review scientific journals, based exclusively on this technology, are: - Symptomatic relief of chronic opioid-resistant pain. - Symptomatic relief of chronic neuropathic and oncological pain. In general, this device in the clinical studies is indicated for forms of severe chronic pain, in particular that which does not respond to other pharmacological and non-pharmacological treatments, including opioids.
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Device Characteristics

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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Analgesic transcutaneous electrical nerve stimulation system An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.
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FDA Product Code

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Product Code Product Code Name
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
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FDA Premarket Submission

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Sterilization

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Storage and Handling

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Clinically Relevant Size

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Device Record Status

25b3621b-7877-4e5e-8131-fe972c9e4fcd
May 07, 2021
1
April 29, 2021
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Alternative and Additional Identifiers Additional Identifiers

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