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Scrambler Therapy® Technology ST-5A

DELTA INTERNATIONAL SERVICES & LOGISTICS SRL · Model ST-5A · UDI-DI 08055205950010

GZJ Prescription
1
510(k) clearances
500
Adverse events (4 deaths)
7
Recalls
186
Facilities

Description

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.

Recalls

DateFirmReason
2011-02-07Neuro Resource Group IncProduct package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.
2008-07-18Synaptic CorpDevice was distributed without marketing approval.
2007-06-29Avazzia, IncPlastic Cases may crack due to manufacturing by the supplier not meeting specifications
2007-06-29Avazzia, IncPlastic Cases may crack due to manufacturing by the supplier not meeting specifications
2007-06-29Avazzia, IncPlastic Cases may crack due to manufacturing by the supplier not meeting specifications
2007-06-29Avazzia, IncPlastic Cases may crack due to manufacturing by the supplier not meeting specifications
2003-05-23RehabilicareIf there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.