CES-Ultra

Basic Information

• Brand Name: CES-Ultra
• Primary DI: M750AR635A
• Version / Model: AR635A
• Catalog Number: CES-Ultra
• Company Name: NEURO-FITNESS LLC
• Labeler DUNS: 078513618
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-12
• Public Version: 4
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: 6c0a8402-f90b-4a8c-a574-3807163fa833

Device Description

Cranial Electrotherapy Stimulator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
JXK	Stimulator, Cranial Electrotherapy	Neurology	882.5800	3

GMDN Terms

Code	Name	Definition	Implantable	Status
61022	Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system	An assembly of portable, battery-powered devices designed to apply noninvasive cranial electrical stimulation (CES) via cranial/peripheral nerves in/around the external ear for the treatment of one or more psychiatric and stress-related disorders (e.g., anxiety, depression, insomnia, migraine); it might additionally be intended for the treatment of autoimmune diseases (e.g., rheumatoid arthritis). It consists of an external pulse generator (EPG) with controls/display, and transcutaneous electrodes for placement on the skin surface in/around the external ear. The device may be used in conjunction with a smartphone for use by a patient and healthcare provider. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M750AR635A	HIBCC

Customer Contacts

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