FDA.reportPublic FDA data

Ibramed

Primary DI
07898961579023
Brand
Ibramed
Company
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Model
NEUROTONUS PORTABLE TENS
Catalog number
01002024
Device description
NEUROTONUS PORTABLE TENS transcutaneous neuromuscular stimulator is a two-channel stimulator with independent controls for current therapies used in TENS (Transcutaneous Electrical Nerve Stimulation).
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131923000NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENSTechlink International2014-07-03GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898961579023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898961579023078989615790237898961579023

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
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
07898961579016IbramedNEURODYN MULTIWAVE2017-03-17

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