Neuro Omega EMG HeadBox Kit

Basic Information

• Brand Name: Neuro Omega EMG HeadBox Kit
• Primary DI: 27290114060817
• Version / Model: Neuro Omega EMG HeadBox Kit
• Catalog Number: 750-020013-00
• Company Name: ALPHA OMEGA ENGINEERING CO. LTD.
• Labeler DUNS: 531856466
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-04
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: ab30e79a-3347-4c58-b871-4a8c581f5915

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
GWF	Stimulator, Electrical, Evoked Response	Neurology	882.1870	2
IKN	Electromyograph, Diagnostic	Physical Medicine	890.1375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11474	Electromyograph	An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	27290114060817	GS1

Premarket Submissions

Submission Number	Supplement Number
K171581	000