FDA.reportPublic FDA data

GLOBUS

Primary DI
08032625829799
Brand
GLOBUS
Company
DOMINO SRL
Model
AXON I MYO PRO
Catalog number
G3197
Device description
The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator.Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.
Published
2024-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071431000GLOBUS GENESY 1100 STIMULATORDomino S.R.L.2007-09-21IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08032625829799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08032625829799080326258297998032625829799

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
565257974
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032625824480GLOBUSG-WaveG80502026-02-23
08032625823315NerveOTXDX500G75702025-07-30
08032625822868GLOBUSVOLTA XG70962024-11-20
08032625822875GLOBUSARPneuroG71862024-11-20
08032625822882GLOBUSCIRCUIT BREAKERG69962024-11-20
08032625822851GLOBUSGENESY 3000G58822024-10-17
08032625824138GLOBUSPREMIUM FITNESSG10682024-10-17
08032625824183GLOBUSPREMIUM SPORT PLUSG20552024-10-17
08032625827535GLOBUSGOLF PROG51472024-10-17
08032625827566GLOBUSPREMIUM SPORTG10702024-10-17
08032625828037GLOBUSGLOBUS PHOENIX WAVEFORM ELITEG55272024-10-17
08032625829775GLOBUSRUNNER PROG66442024-10-17
08032625829782GLOBUSCYCLING PROG64532024-10-17
08032625829805GLOBUSGLOBUS REVO STCG56012024-10-17
08032625829812GLOBUSGLOBUS REVO TO GOG55982024-10-17
08032625821137GLOBUSDIACARE 5500 PROG64572024-09-04
08032625822837GLOBUSGENESY 600G69832024-09-04
08032625822844GLOBUSGENESY 1500G64672024-09-04
08032625825265GLOBUSGENESY 1100G20522024-09-04
08032625827528GLOBUSTRIATHLON PROG62652024-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.IPF2026-06-04
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
08032625824480GLOBUSDOMINO SRLLIH2026-02-23
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
08720618311139Sonopuls 494Enraf-Nonius B.V.IPF2025-02-11
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
08032625822868GLOBUSDOMINO SRLIPF2024-11-20
08032625822868GLOBUSDOMINO SRLLIH2024-11-20
08032625822875GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLLIH2024-11-20
08032625822882GLOBUSDOMINO SRLIPF2024-11-20
08032625822882GLOBUSDOMINO SRLLIH2024-11-20
08809851470053eMVFitWEERO Co., Ltd.IPF2024-10-22