CES-Ultra CES-Ultra

GUDID M750AR635A0

Cranial Electrotherapy Stimulator

NEURO-FITNESS LLC

Psychiatric-therapy periauricular nerve transcutaneous electrical stimulator Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system

• Primary Device ID: M750AR635A0
• NIH Device Record Key: d0fd2eae-ed99-4d24-ac2b-68bcb7702936
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CES-Ultra
• Version Model Number: AR635A
• Catalog Number: CES-Ultra
• Company DUNS: 078513618
• Company Name: NEURO-FITNESS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com
• Phone: 866-937-4237
• Email: info@cesultra.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M750AR635A0 [Primary]

FDA Product Code

• JXK: Stimulator, Cranial Electrotherapy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-06-30

On-Brand Devices [CES-Ultra]

• M750AR635A0: Cranial Electrotherapy Stimulator
• M750AR635A: Cranial Electrotherapy Stimulator