Cervella Cervella

GUDID 00860001493306

Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo headphones with integrated treatment electrodes. Cervella provides stimulation current intensity ranging from 50uA - 500uA in 50uA increments and user-selectable frequency presets of 0.5Hz, 1.5Hz, and 100Hz.

INNOVATIVE NEUROLOGICAL DEVICES LLC

Psychiatric-therapy periauricular nerve transcutaneous electrical stimulator

• Primary Device ID: 00860001493306
• NIH Device Record Key: 6e1bde1c-e2f3-44dc-892c-1e55648005ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervella
• Version Model Number: Cervella CES
• Catalog Number: Cervella
• Company DUNS: 081278318
• Company Name: INNOVATIVE NEUROLOGICAL DEVICES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us
• Phone: (855) 413-3300
• Email: support@cervella.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001493306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182311

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: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-04-30