Duns Number:339950851
Device Description: The Scrambler Therapy® Technology ST-5A is a patented non-invasive electro-analgesia devic 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.
Catalog Number
-
Brand Name
Scrambler Therapy® Technology ST-5A
Version/Model Number
ST-5A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
25b3621b-7877-4e5e-8131-fe972c9e4fcd
Public Version Date
May 07, 2021
Public Version Number
1
DI Record Publish Date
April 29, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |