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Scrambler Therapy Technology (Model ST-5A)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201458

by Delta International Services & Logistics S.R.L

Identifiers

510(k) Number
K201458 FDA 510(k)
FDA Product Code
GZJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5890 FDA 510(k)
Regulation Number
882.5890 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Scrambler Therapy Technology (Model ST-5A) is a non-invasive electro-analgesia device with 5 channels that deliver low-intensity stimuli (max. 5 mA) generated by a completely automated treatment program.

This device is supplied by Delta International Services & Logistics S.R.L and is FDA 510(k) cleared (K201458) with product code GZJ. It is intended for use in neurology applications and is designed for the non-invasive treatment of chronic neuropathic and oncologic pain.

Frequently asked questions

What is the Scrambler Therapy Technology ST-5A device used for?

The Scrambler Therapy Technology ST-5A is a non-invasive electro-analgesia device designed for the treatment of chronic neuropathic and oncologic pain in neurology applications. It delivers low-intensity stimuli through 5 channels via an automated treatment program.

How is the Scrambler Therapy Technology ST-5A supplied?

The device is supplied by Delta International Services & Logistics S.R.L, with the manufacturer located in Rome, Italy. It is FDA 510(k) cleared with product code GZJ and clearance number K201458.

What are the technical specifications of the Scrambler Therapy Technology ST-5A?

The ST-5A is a non-invasive electro-analgesia device with 5 channels that deliver low-intensity stimuli with a maximum intensity of 5 mA. It operates through a completely automated treatment program designed for pain management applications.

Is the Scrambler Therapy Technology ST-5A reusable or single-use?

The device information does not specify whether the ST-5A is designed for single-use or multiple uses. For proper usage and disposal instructions, users should refer to the manufacturer's guidelines or contact Delta International Services & Logistics S.R.L directly.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K201458 - Scrambler Therapy Technology (Model ST-5A), Scrambler Therapy® Technology ST-5A, Scrambler Therapy Technology (Model ST-5A) (K201458) — FDA 510 (k ..., Scrambler Therapy® MC-5A device - st-team.eu, Scrambler Therapy® Medical Device

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Delta International Services & Logistics S.R.L

Sources (1)

  • FDA 510(k) K201458 24 fields · synced Oct 1, 2026