FDA.reportPublic FDA data

MES 9000 Static Electromyography Scanner

Primary DI
D792N150MES0
Brand
MES 9000 Static Electromyography Scanner
Company
MYOTRONICS NOROMED, INC
Model
Static EMG Scanner
Device description
"Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical ""noise"", provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results.In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise."
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback
IKNElectromyograph, Diagnostic
KZMDevice, Muscle Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
KZMDevice, Muscle MonitoringPhysical 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
D792N9150PackageHIBCC2In Commercial Distribution
D792N150MES0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electromyographicA small unit dedicated to detect and record the electrical activity of muscles in the form of an electromyogram (EMG) obtained through a connected cable/lead. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals/information measured and provided by this module. By measuring the electrical activity generated in the musculature, muscular disorders can be diagnosed.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2062434214info@myotronics.com

Regulatory Flags#

DUNS number
053824652
Device count
1
Serial number
true
Manufacturing date on label
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
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
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

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Primary DI, Brand, Company table
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B758000VMPLU0ViMove+DORSAVI LTDIKN2023-08-30
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00190376458601SafeOpALPHATEC SPINE, INC.IKN2023-02-12
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00092237623817TheraTouch UX2Drive Devilbiss HealthcareHCC2022-09-07
00195377049131PULSENuvasive, Inc.IKN2022-05-06
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