Scrambler Therapy® Technology ST-5A

GUDID 08055205950010

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.

DELTA INTERNATIONAL SERVICES & LOGISTICS SRL

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 08055205950010
• NIH Device Record Key: 25b3621b-7877-4e5e-8131-fe972c9e4fcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scrambler Therapy® Technology ST-5A
• Version Model Number: ST-5A
• Company DUNS: 339950851
• Company Name: DELTA INTERNATIONAL SERVICES & LOGISTICS SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055205950010 [Primary]

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-07
• Device Publish Date: 2021-04-29