Neuroglide Back Neck Pad

Basic Information

• Brand Name: Neuroglide Back Neck Pad
• Primary DI: G067A001500
• Version / Model: T162020
• Catalog Number: A-00150
• Company Name: Eva Medtec, Inc
• Labeler DUNS: 100379368
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-26
• Public Version: 1
• Public Version Date: 2021-06-03
• Public Version Status: New
• Public Device Record Key: 0860dcf4-a69f-4bbb-8bf6-f3d8b7ebcc95

Device Description

Back/Neck Therapy attachment used in conjunction with the Neuroglide Controller Unit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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
IRP	Massager, Powered Inflatable Tube	Physical Medicine	890.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34488	Bed/chair electric massager	A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G067A001500	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K202693	000