K7 EMG Electromyograph

Basic Information

• Brand Name: K7 EMG Electromyograph
• Primary DI: D79209950
• Version / Model: EMG
• Catalog Number: 0995
• Company Name: MYOTRONICS NOROMED, INC
• Labeler DUNS: 053824652
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-18
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a822ed6c-e4a7-4fa0-99e0-6a519bc9b092

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.

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
KZM	Device, Muscle Monitoring	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	D79209950	HIBCC

Customer Contacts

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