AccessGUDID - DEVICE: Cervella (00860001493306)

GUDID

Device Identifier (DI) Information

Brand Name: Cervella
Version or Model: Cervella CES
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Cervella
Company Name: INNOVATIVE NEUROLOGICAL DEVICES LLC

Primary DI Number: 00860001493306
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081278318 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXK	Stimulator, Cranial Electrotherapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182311	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e1bde1c-e2f3-44dc-892c-1e55648005ba
Public Version Date: November 23, 2021
Public Version Number: 3
DI Record Publish Date: April 30, 2019