Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006153348

FEI Number

3006153348

Entity Name

DOMINO S.R.L.

City/State/Country

Codogne Treviso, IT

Establishment Address

via Vittorio Veneto 52, Codogne Treviso 31013, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DOMINO SRL (Owner Number: 9090480)

Owner / Operator Contact Address

via Vittorio Veneto 52, --, Codogne, IT-TV 31013, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K061632

PMA Number

N/A

All Registered Proprietary Names

Electrodes 50 x 90 Plus Electrodes 50 x 50 Plus Ergo System DX500 Soccer Pro Cycling Pro Triathlon Pro Premium Sport Premium Sport Plus Premium Fitness Golf Pro Runner Pro Bio Box Pro Volta X Genesy 600 Axon I Myo Pro Activa 700 Globus Revo STC DX1000 Circuit Breaker Genesy 1500 Globus Phoenix Waveform Pro Genesy 1100 Globus Revo To Go Globus Phoenix Waveform Elite G-Wave Genesy 3000 Diacare 8000 Pro Tecar Beauty 7000 Diacare 5500 Pro Diacare 7000 Pro Physioplate DX500 Soccer Pro Cycling Pro Triathlon Pro Premium Sport Premium Sport Plus Premium Fitness Golf Pro Runner Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-12-14
KHX	Platform, Force-Measuring	Physical Medicine	Class 1	890.1575	2006-08-01
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2007-06-18
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2007-11-26
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2007-11-26
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2007-11-26
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-06-13
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2006-08-01
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2007-06-18

Official Correspondent

BRENO LEITE

US Agent Details

Breno Leite Business: Globus Sport Health Technologies Email: info@globususa.com Phone: (786) 6784637

Related Public Records

Same Entity

DOMINO SRL

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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

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3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006153348. Last updated year: 2026. Please use registration number 3006153348 when referencing this establishment in official correspondence.