FDA.reportPublic FDA data

Ibramed

Primary DI
07898966442698
Brand
Ibramed
Company
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Model
NEURODYN V2.0
Device description
STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL
Published
2026-04-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210572000Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos2021-05-11IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898966442698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898966442698078989664426987898966442698

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
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
07898961579047IbramedNEUROTONUS II010020202017-10-13
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
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
00816864021682accufitMETTLER ELECTRONICS CORP.IPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
00810188050052L360 Thigh SystemBioness Medical, Inc.IPF2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.IPF2025-07-18
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050144L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050168L100 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050236L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050250L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050267L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050281L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050298L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050304L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050311L300 Go SystemBioness Medical, Inc.IPF2025-07-17