FDA.reportPublic FDA data

Ibramed

Primary DI
07898961579047
Brand
Ibramed
Company
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Model
NEUROTONUS II
Catalog number
01002020
Device description
NEUROTONUS II transcutaneous neuromuscular stimulator is a four-channels stimulator with independent controls for current therapies used in: TENS (Transcutaneous Electrical Nerve Stimulation), FES
Published
2017-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131917000NEURODYN COMPACT, NEURODYN IIIbramed Equipamentos Medicos2014-04-29IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898961579047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898961579047078989615790477898961579047

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality physical therapy system, simultaneous, professional-useAn assembly of electrically-powered devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.

Regulatory Flags#

DUNS number
903359565
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898961579023IbramedNEUROTONUS PORTABLE TENS010020242017-10-13
07898961579030IbramedNEUROTONUS PORTABLE TENS FES010020252017-10-13
07898961579054IbramedNEUROTONUS Compact010020212017-10-13
07898961579061IbramedCELLEBRA Compact 1MHz010040192017-10-13
07898961579078IbramedCELLEBRA Compact 3MHz010040202017-10-13
07898961579085IbramedCELLEBRA III010040182017-10-13
07898961579092IbramedCELLEBRA010040212017-10-13
07898961579108IbramedNEUROTONUS MULTIWAVE010020232017-10-13
07898961579115IbramedAUSSIE SPORT010020222017-10-13
07898966442551IbramedNEURODYN AUSSIE V2.02026-04-22
07898966442698IbramedNEURODYN V2.02026-04-22
07898961579139IbramedDermotonus Esthetic010060052017-10-13
07898966442933IbramedCryotecar2025-02-25
07898966442940IbramedNeartek2025-02-25
07898966442957IbramedDermotonus Esthetic2025-02-25
07898966442964IbramedHooke2025-02-25
07898961579146IbramedHF IBRAMED10070112017-10-13
07898961579122IbramedDermotonus Slim 010060062017-10-13
07898961579016IbramedNEURODYN MULTIWAVE2017-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08032625822875GLOBUSDOMINO SRLIPF2024-11-20
08032625822882GLOBUSDOMINO SRLIPF2024-11-20
08809851470053eMVFitWEERO Co., Ltd.IPF2024-10-22
08032625822851GLOBUSDOMINO SRLIPF2024-10-17
08032625828037GLOBUSDOMINO SRLIPF2024-10-17
08032625829799GLOBUSDOMINO SRLIPF2024-10-17
08032625829805GLOBUSDOMINO SRLIPF2024-10-17
08032625829812GLOBUSDOMINO SRLIPF2024-10-17
B108899PO11C1ENUS0150EMSCULPT NEOBTL INDUSTRIES LIMITEDIPF2024-09-23
08032625822837GLOBUSDOMINO SRLIPF2024-09-04
08032625822844GLOBUSDOMINO SRLIPF2024-09-04
08032625825265GLOBUSDOMINO SRLIPF2024-09-04
08032625828020GLOBUSDOMINO SRLIPF2024-09-04
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
17540176030147ReGraspRehabtronics IncIPF2024-02-23
17540176030154ReGraspRehabtronics IncGZI2024-02-23
17540176030161ReGraspRehabtronics IncGZI2024-02-23
17540176030178ReGraspRehabtronics IncGZI2024-02-23
17540176030185ReGraspRehabtronics IncGZI2024-02-23
17540176030192ReGraspRehabtronics IncGZI2024-02-23