FDA.reportPublic FDA data

Cervella

Primary DI
00860001493306
Brand
Cervella
Company
INNOVATIVE NEUROLOGICAL DEVICES LLC
Model
Cervella CES
Catalog number
Cervella
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.
Published
2019-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXKStimulator, Cranial Electrotherapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXKCranial Electrotherapy Stimulator To Treat DepressionNeurology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182311000CervellaInnovative Neurological Devices, LLC2019-03-07QJQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001493306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001493306008600014933068600014933060860001493306

GMDN Terms#

Term, Definition table
TermDefinition
Psychiatric-therapy periauricular nerve transcutaneous electrical stimulatorA portable, battery-powered device designed to apply noninvasive cranial electrical stimulation (CES) via cranial/peripheral nerves around the external ear for the treatment of psychiatric and stress-related disorders such as anxiety, depression, and insomnia. It consists of an external pulse generator (EPG) with controls/display, and transcutaneous electrodes for placement on the skin surface around the external ear (e.g., the area below the ear, ear lobe, tragus). The device may be used in conjunction with a smartphone by a patient or healthcare provider in the home and healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(855) 413-3300support@cervella.us

Regulatory Flags#

DUNS number
081278318
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17314581000107Flow NeuroscienceFlow Neuroscience ABJXK2026-07-24
17314585010010Flow NeuroscienceFlow Neuroscience ABJXK2026-07-24
17314585010003Flow NeuroscienceFlow Neuroscience ABJXK2026-07-02
07314581000001Flow NeuroscienceFlow Neuroscience ABJXK2026-06-24
00857869005277Alpha-Stim Conducting SolutionElectromedical Products International, Inc.JXK2021-11-30
00857869005284Alpha-Stim Conducting SolutionElectromedical Products International, Inc.JXK2021-11-30
08908008085406Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDJXK2021-03-12
B788KS02001NexalinNEXALIN TECHNOLOGYJXK2019-10-07
B788KS02000NexalinNEXALIN TECHNOLOGYJXK2019-10-01
08908008085314Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDJXK2019-04-30
089080080853217E WellnessSYRMA JOHARI MEDTECH LIMITEDJXK2019-04-30
M750AR635A0CES-UltraNEURO-FITNESS LLCJXK2017-06-30
M750AR635ACES-UltraNEURO-FITNESS LLCJXK2017-02-12
00857869005239TruDenta Earclip Electrode PadElectromedical Products International, Inc.JXK2015-06-30
00857869005161Alpha-Stim Earclip Electrode (M)Electromedical Products International, Inc.JXK2014-08-29
00857869005178Alpha-Stim Earclip Electrode (AID)Electromedical Products International, Inc.JXK2014-08-29
00857869005031Alpha-Stim Earclip Electrode PadElectromedical Products International, Inc.JXK2014-08-25
00857869005079Alpha Conducting SolutionElectromedical Products International, Inc.JXK2014-08-25
00857869005086Alpha Conducting Solution Electromedical Products International, Inc.JXK2014-08-25
00857869005093Alpha-Stim Earclip Electrode (CE3)Electromedical Products International, Inc.JXK2014-08-25
00857869005130Alpha-Stim Earclip Electrode (AID)Electromedical Products International, Inc.JXK2014-08-25