K7 Evaluation System-EMG

Primary DI
D79209930
Brand
K7 Evaluation System-EMG
Company
MYOTRONICS NOROMED, INC
Model
K7/EMG
Device description
Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles.
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
IKNElectromyograph, Diagnostic
KZMDevice, Muscle Monitoring
NFSDevice, Jaw Tracking, For Monitoring Jaw Positions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKNElectromyograph, DiagnosticPhysical Medicine2
KZMDevice, Muscle MonitoringPhysical Medicine2
NFSDevice, Jaw Tracking, For Monitoring Jaw PositionsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D07920978PackageHIBCC1In Commercial Distribution
D79209930PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Jaw physiology evaluation systemAn assembly of mains electricity (AC-powered) devices designed to record parameters for mandibular and muscles of mastication function, primarily to aid in the diagnosis and treatment of temperomandibular joint (TMJ) and myofascial pain dysfunction (MPD) disorders, and for orthodontic, denture, and reconstruction patient evaluation. It typically uses surface electromyography to evaluate muscle groups at rest or in function; sonography to detect sounds/vibrations from the TMJ joint and/or other computer-based system to non-invasively track the mandible in function or identify its position in space relative to the skull.

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
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D792N9200A0MES 9000 Dynamic EMGMES 9000 EMG2017-02-11
D792N9600A0MES 9000 Muscle TesterMuscle Tester2016-09-19
D79243001Myotrode SG Solid Gel TENS Electrodes43002016-09-19
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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
D0792009780K7 Evaluation System-ESGK7/ESG2016-09-19
D07920978K7 Evaluation System-EMGK7/EMG2016-09-19

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