FDA.reportPublic FDA data

Norotrode 20

Primary DI
D792N12011
Brand
Norotrode 20
Company
MYOTRONICS NOROMED, INC
Model
N120
Device description
NOROTRODES are silver-silver chloride electrodes for surface EMG applications. Contact surfaces pre-jelled with hypoallergenic jel that is water soluble for quick cleanup. Mounted on hypoallergenic adhesive. Silver snap connectors.
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
IKNElectromyograph, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKNElectromyograph, DiagnosticPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013399000MODEL MES-9000/EMG SYSTEMMyotronics-Noromed, Inc.2001-11-13HCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D792N12012PackageHIBCC24In Commercial Distribution
D792N12013PackageHIBCC240In Commercial Distribution
D792N12011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeAn electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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
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
D79240602Myotrode One With Gel40602016-09-19
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
00190376509747SafeOp 3ALPHATEC SPINE, INC.IKN2026-03-24
00763000886790N/aMEDTRONIC XOMED, INC.IKN2025-06-23
08056446901106NExT-DOCKINGEB NEURO SPAIKN2025-05-22
08056446901113NExT-PADEB NEURO SPAIKN2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAIKN2025-05-22
08056446901137NExT-HSEB NEURO SPAIKN2025-05-22
08056446901168NExT-AMPEB NEURO SPAIKN2025-05-22
08056446901199NExT-ASEB NEURO SPAIKN2025-05-22
08056446901205NExT StationEB NEURO SPAIKN2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAIKN2025-05-19
00190376517506SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
00190376530024SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
B758000VMPLU0ViMove+DORSAVI LTDIKN2023-08-30
00195377153951PULSENuvasive, Inc.IKN2023-07-11
00195377153968PULSENuvasive, Inc.IKN2023-07-11
00195377153975PULSENuvasive, Inc.IKN2023-07-11
00195377060761PULSENuvasive, Inc.IKN2023-07-06
00195377060778PULSENuvasive, Inc.IKN2023-07-06
00195377153807PULSENuvasive, Inc.IKN2023-05-02
00195377153814PULSENuvasive, Inc.IKN2023-05-02
00195377083272NVM5Nuvasive, Inc.IKN2023-04-13
00195377097415NVM5Nuvasive, Inc.IKN2023-04-13
00195377097422NVM5Nuvasive, Inc.IKN2023-04-13
00195377097439NVM5Nuvasive, Inc.IKN2023-04-13
00190376458601SafeOpALPHATEC SPINE, INC.IKN2023-02-12
00190376459035SafeOpALPHATEC SPINE, INC.IKN2023-02-12
00195377108128PULSENuvasive, Inc.IKN2022-06-30
00195377108135PULSENuvasive, Inc.IKN2022-06-30
00195377049131PULSENuvasive, Inc.IKN2022-05-06
00195377049148PULSENuvasive, Inc.IKN2022-05-06