FDA.reportPublic FDA data

MES 9000 Dynamic EMG

Primary DI
D792N9200A0
Brand
MES 9000 Dynamic EMG
Company
MYOTRONICS NOROMED, INC
Model
MES 9000 EMG
Device description
The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its raw state or as integrated data.The powerful and user-friendly software simplifies the recording of multiple muscle groups of antagonist and synergist muscles to facilitate assessment and case documentation. In addition, the system includes pre-programmed protocols and analysis for assessment, muscle education and relaxation training. The clinician may also program custom protocols - quickly and simply.
Published
2017-02-11
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
D792N9200A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Virtual-display rehabilitation system, non-supportive, clinicalAn assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement (e.g., reaching, grasping, balance); it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, movement tracking camera, software) that communicate wirelessly to provide a virtual-display interface.

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
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

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