FDA.reportPublic FDA data

GLOBUS

Primary DI
08032625827528
Brand
GLOBUS
Company
DOMINO SRL
Model
TRIATHLON PRO
Catalog number
G6265
Device description
The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in the family comes with a menu to navigate betweendifferent stimulation programs. The Stimulation Programs have been subdivided in menus and submenus to facilitate use for various types of uses.
Published
2024-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061632000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061632000GLOBUS PREMIUM MUSCLE STIMULATORDomino S.R.L.2007-04-30NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08032625827528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08032625827528080326258275288032625827528

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
No natural rubber latex
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
08032625829799GLOBUSAXON I MYO PROG31972024-10-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00850051584048Neuro20 PRO SystemNEURO20 TECHNOLOGIES CORP.NGX2026-05-05
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810140062680RENPHOJoicom CorporationNGX2025-10-20
00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNGX2025-09-29
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NGX2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13
00850073128091AVCOOADP HEALTH LIMITEDNGX2025-05-26
00850073128084AVCOOADP HEALTH LIMITEDNGX2025-05-26
00850073128046AVCOOADP HEALTH LIMITEDNGX2025-04-03