MES 9000 Muscle Tester

GUDID D792N9600A0

Noromed computerized manual muscle testing offers manual muscle testing at its best by bringing science to what once was an art. The muscle testing hardware includes an ergonomic force gauge and five attachments to choose from which provide easy, comfortable testing of all muscle groups - large and small. Now you can perform real time strength testing - quickly and easily - and all fully documented by the computer interface. The flexibility of the system allows you to use pre-programmed established protocols or create your own. Designed to meet your needs, the software calculates the statistics appropriate to each test as well as generating a wide variety of documentation to fit your specific needs. This documentation includes: Supportive documentation reports which contain the graphic reports and profiles of the actual test data. Reports included are: •A composite report of individual test results by protocol and muscles tested as well as calculated deficits. •A test comparison report which collects and displays the patient's historical results. •A Myotest data report which presents both statistical data and graphical data of the individual test broken down by trial.

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 IDD792N9600A0
NIH Device Record Key8cf90e98-f089-42ef-8e0e-0f6df10cbef3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMES 9000 Muscle Tester
Version Model NumberMuscle Tester
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
HIBCCD792N9600A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCCDevice, Biofeedback

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 Date2016-09-19

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.