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 ID00860001493306
NIH Device Record Key6e1bde1c-e2f3-44dc-892c-1e55648005ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervella
Version Model NumberCervella CES
Catalog NumberCervella
Company DUNS081278318
Company NameINNOVATIVE NEUROLOGICAL DEVICES LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us
Phone(855) 413-3300
Emailsupport@cervella.us

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001493306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXKStimulator, Cranial Electrotherapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-05
Device Publish Date2019-04-30

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