MES 9000 Static Electromyography Scanner

Basic Information

• Brand Name: MES 9000 Static Electromyography Scanner
• Primary DI: D792N150MES0
• Version / Model: Static EMG Scanner
• Company Name: MYOTRONICS NOROMED, INC
• Labeler DUNS: 053824652
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6efc8710-51c8-4ebe-a837-f087e2b7ce16

Device Description

Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "noise", provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results. In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCC	Device, Biofeedback	Neurology	882.5050	2
KZM	Device, Muscle Monitoring	Physical Medicine	890.1375	2
IKN	Electromyograph, Diagnostic	Physical Medicine	890.1375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37208	Patient monitoring system module, electromyographic	A small unit dedicated to detect and record the electrical activity of muscles in the form of an electromyogram (EMG) obtained through a connected cable/lead. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals/information measured and provided by this module. By measuring the electrical activity generated in the musculature, muscular disorders can be diagnosed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D792N150MES0	HIBCC
Package	D792N9150	HIBCC		2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K013399	000