FDA.reportPublic FDA data

K7 Evaluation System-EMG

Primary DI
D07920978
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
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZMDevice, Muscle Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZMDevice, Muscle MonitoringPhysical Medicine2

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2062434214info@myotronics.com

Regulatory Flags#

DUNS number
053824652
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003499900BioEMGBio-Research Associates, Inc.KZM2023-06-22
00860003499948BioPAKBio-Research Associates, Inc.KZM2023-06-22
00860003499955M-ScanBio-Research Associates, Inc.KZM2023-06-22
00860003499962M-ScanBio-Research Associates, Inc.KZM2023-06-22
15694311111665Noxturnal US APPNox Medical ehf.KZM2021-10-18
15694311111610Nox A1® EEG 5 Lead Gold Electrode CableNox Medical ehf.KZM2021-09-07
15694311111627Nox A1® EEG Head Cable Nox Medical ehf.KZM2021-09-07
15694311111566Nox A1s RecorderNox Medical ehf.KZM2021-07-10
15694311111580Nox A1s SystemNox Medical ehf.KZM2021-07-10
15694311111597Nox C1s KitNox Medical ehf.KZM2021-07-10
15694311110682Nox A1 Starter Sensor Kit, AdultNox Medical ehf.KZM2021-02-03
15694311110699Nox A1 Starter Sensor Kit, PediatricNox Medical ehf.KZM2021-02-03
15694311111498Nox C1 Access PointNox Medical ehf.KZM2021-02-03
15694311111504Nox C1 KitNox Medical ehf.KZM2021-02-03
00860001651911HindexRVHHS SYSTEMS, INC.KZM2021-01-20
15694311110095Nox A1 Carry CaseNox Medical ehf.KZM2020-04-27
15694311110453Nox A1 EEG 5 Lead Gold Electrode CableNox Medical ehf.KZM2020-04-27
15694311110521Nox A1 EEG Head CableNox Medical ehf.KZM2020-04-27
15694311110019Noxturnal APPNox Medical ehf.KZM2020-02-24
15694311110590Nox C1 Access PointNox Medical ehf.KZM2020-02-24
15694311110903Nox A1 RecorderNox Medical ehf.KZM2020-02-24
15694311111146Nox C1 KitNox Medical ehf.KZM2020-02-24
15694311111368Noxturnal PSG CDNox Medical ehf.KZM2020-02-24
15694311111375Nox A1 SystemNox Medical ehf.KZM2020-02-24
00860001651904HindexRVHHS SYSTEMS, INC.KZM2019-04-26
B179THN2TEETHANBTS SPAKZM2017-09-26
B179THN1TEETHANBTS SPAKZM2017-09-26
D792N9200A0MES 9000 Dynamic EMGMYOTRONICS NOROMED, INCKZM2017-02-11
D79209750K7 Evaluation System-ESGMYOTRONICS NOROMED, INCKZM2016-09-19
D79209930K7 Evaluation System-EMGMYOTRONICS NOROMED, INCKZM2016-09-19