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

• Primary Device ID: D792N9600A0
• NIH Device Record Key: 8cf90e98-f089-42ef-8e0e-0f6df10cbef3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MES 9000 Muscle Tester
• Version Model Number: Muscle Tester
• Company DUNS: 053824652
• Company Name: MYOTRONICS NOROMED, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D792N9600A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013399

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

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