MES 9000 Dynamic EMG

GUDID D792N9200A0

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.

MYOTRONICS NOROMED, INC

Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical
Primary Device IDD792N9200A0
NIH Device Record Key26f6028c-cd2a-483b-8c14-d03d7d115ea5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMES 9000 Dynamic EMG
Version Model NumberMES 9000 EMG
Company DUNS053824652
Company NameMYOTRONICS NOROMED, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD792N9200A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KZMDevice, Muscle Monitoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-11

Devices Manufactured by MYOTRONICS NOROMED, INC

D79244500 - J5 Myo-Monitor2019-10-23 The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication.
D79245000 - BNS-40 Home Treatment Unit2019-10-23 The BNS-40 is a miniaturized version of the Myomonitor designed to allow the patient to safely apply electrical stimulation whil
D79209830 - K7 ESG-2 Electrosonograph2018-07-06 TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint,
D79240602 - Myotrode One With Gel2018-07-06 Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.
D79240702 - Myotrode One without Gel2018-07-06 Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with sideburns or a beard.
D79243003 - Myotrode SG Solid Gel TENS Electrodes2018-07-06 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total). A revolutionary electrode designed especially for u
D792N12013 - Norotrode 202018-07-06 NOROTRODES are silver-silver chloride electrodes for surface EMG applications. Contact surfaces pre-jelled with hypoallergenic
D792N150MES0 - MES 9000 Static Electromyography Scanner2018-07-06 Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "no

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.