FDA.reportPublic FDA data

Ibramed

Primary DI
07898961579016
Brand
Ibramed
Company
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Model
NEURODYN MULTIWAVE
Device description
STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL
Published
2017-03-17
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
GZIStimulator, Neuromuscular, External Functional
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131629000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131629000NEURODYN MULTIWAVE, AUSSIE SPORTIbramed Equipamentos Medicos2013-11-26IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898961579016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898961579016078989615790167898961579016

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous electrical stimulation system, line-poweredAn assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion.

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-03
08809851470145WavefacialWEERO Co., Ltd.GZJ2026-06-22
08809851470145WavefacialWEERO Co., Ltd.IPF2026-06-22
G345SL2000CIONICCionic, Inc.IPF2026-06-04
G345SL2000CIONICCionic, Inc.GZI2026-06-04
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
04048223122235Stim2GoPajunk GmbH MedizintechnologieIPF2026-05-21
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 SRLLIH2026-02-23
08032625824480GLOBUSDOMINO SRLIPF2026-02-23