Duns Number:081278318
Device Description: Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo 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.
Catalog Number
Cervella
Brand Name
Cervella
Version/Model Number
Cervella CES
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182311
Product Code
JXK
Product Code Name
Stimulator, Cranial Electrotherapy
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 1 |