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Scrambler Therapy® Technology ST-5A

FDA UDI

Class II (US FDA UDI)

by Delta International Services & Logistics Srl

Identity

Trade Name
Scrambler Therapy® Technology ST-5A FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
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. FDA UDI
Model / Reference
ST-5A FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
08055205950010 FDA UDI
FDA Product Code
GZJ FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Scrambler Therapy® Technology ST-5A by Delta International Services & Logistics Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Delta International Services & Logistics Srl

Sources (1)

  • FDA UDI 25b3621b-7877-4e5e-8131-fe972c9e4fcd 33 fields · synced May 30, 2026