Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012440948

FEI Number

3012440948

Entity Name

DELTA INTERNATIONAL SERVICE & LOGISTICS S.R.L.

City/State/Country

Roma, IT

Establishment Address

Piazza Adriana 4, Roma 00193, IT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Foreign Private Label Distributor,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Delta international Service & Logistics S.r.l. (Owner Number: 10050207)

Owner / Operator Contact Address

Piazza Adriana 4, Roma, IT-RM 00193, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201458

PMA Number

N/A

All Registered Proprietary Names

Scrambler Therapy® Technology ST-5A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2021-04-26

Official Correspondent

Mariella Giorgieri

US Agent Details

Emily Matorin Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Delta international Service & Logistics S.r.l.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012440948. Last updated year: 2026. Please use registration number 3012440948 when referencing this establishment in official correspondence.