FDA.reportPublic FDA data

Myotrode One With Gel

Primary DI
D79240602
Brand
Myotrode One With Gel
Company
MYOTRONICS NOROMED, INC
Model
4060
Device description
Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUWStimulator, Muscle, Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUWStimulator, Muscle, Powered, DentalPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040400000MYO-TRODE SG DISPOSABLE ELECTRODEMyotronics-Noromed, Inc.2004-07-20NUW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79240602PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2062434214info@myotronics.com

Regulatory Flags#

DUNS number
053824652
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D79261451Myotronics 6145 Duotrodes 61452016-09-19
D792N12011Norotrode 20N1202016-09-19
D7921013Monotrode 1011012016-09-19
D792N36010Noromed NT-360 InclinometerNT3602017-02-11
D792N9000M0MES 9000 Musculoskeletal System N9000M2016-09-19
D792N9200A0MES 9000 Dynamic EMGMES 9000 EMG2017-02-11
D792N9600A0MES 9000 Muscle TesterMuscle Tester2016-09-19
D79243001Myotrode SG Solid Gel TENS Electrodes43002016-09-19
D79240702Myotrode One without Gel40702016-09-19
D79244500J5 Myo-MonitorJ544502016-08-18
D79245000BNS-40 Home Treatment UnitBNS-4045002016-08-18
D79209830K7 ESG-2 ElectrosonographESG-209832016-08-18
D79243003Myotrode SG Solid Gel TENS Electrodes43002016-09-19
D792N12013Norotrode 20N1202016-09-19
D792N150MES0MES 9000 Static Electromyography ScannerStatic EMG Scanner2016-09-19
D792N91500MES 9000 Musculoskeletal System N9000M2016-09-19
D79209750K7 Evaluation System-ESGK7/ESG2016-09-19
D79209930K7 Evaluation System-EMGK7/EMG2016-09-19
D0792009780K7 Evaluation System-ESGK7/ESG2016-09-19
D07920978K7 Evaluation System-EMGK7/EMG2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B108785APMMUS10EMFACE controllerBTL INDUSTRIES LIMITEDNUW2023-06-28
04983087012394D functionITO CO., LTD.NUW2021-09-09
D79243001Myotrode SG Solid Gel TENS ElectrodesMYOTRONICS NOROMED, INCNUW2016-09-19
D7921013Monotrode 101MYOTRONICS NOROMED, INCNUW2016-09-19
D79240702Myotrode One without GelMYOTRONICS NOROMED, INCNUW2016-09-19
D79243003Myotrode SG Solid Gel TENS ElectrodesMYOTRONICS NOROMED, INCNUW2016-09-19
D79244500J5 Myo-MonitorMYOTRONICS NOROMED, INCNUW2016-08-18
D79245000BNS-40 Home Treatment UnitMYOTRONICS NOROMED, INCNUW2016-08-18