FDA.reportPublic FDA data

CES-Ultra

Primary DI
M750AR635A0
Brand
CES-Ultra
Company
NEURO-FITNESS LLC
Model
AR635A
Catalog number
CES-Ultra
Device description
Cranial Electrotherapy Stimulator
Published
2017-06-30
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
QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXKCranial Electrotherapy Stimulator To Treat DepressionNeurology3
QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or AnxietyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062284000CES ULTRANeuro-Fitness, LLC2007-04-05QJQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M750AR635A0PrimaryHIBCC0

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
866-937-4237info@cesultra.com
425-222-0830admin@cesultra.com

Regulatory Flags#

DUNS number
078513618
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M750AR635A2Calm UltraAR635ACalm Ultra2026-05-21
M750AR635A1CES-UltraAR635ACES-Ultra2017-02-12
M750AR635ACES-UltraAR635ACES-Ultra2017-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M750AR635A2Calm UltraNEURO-FITNESS LLCQJQ2026-05-21
00860010064634GenesisNeurofield, Inc.QJQ2026-05-07
05070002841210Modius CalmNEUROVALENS LIMITEDQJQ2025-04-04
05070002841203Modius SleepNEUROVALENS LIMITEDQJQ2025-01-23
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
08908008085383Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDQJQ2020-10-30
B788KS02001NexalinNEXALIN TECHNOLOGYJXK2019-10-07
B788KS02000NexalinNEXALIN TECHNOLOGYJXK2019-10-01
00860001493306CervellaINNOVATIVE NEUROLOGICAL DEVICES LLCJXK2019-04-30
08908008085314Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDJXK2019-04-30
08908008085314Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDQJQ2019-04-30
089080080853217E WellnessSYRMA JOHARI MEDTECH LIMITEDJXK2019-04-30
089080080853217E WellnessSYRMA JOHARI MEDTECH LIMITEDQJQ2019-04-30
M750AR635A1CES-UltraNEURO-FITNESS LLCQJQ2017-02-12
M750AR635ACES-UltraNEURO-FITNESS LLCJXK2017-02-12
08908008085086Solace Lifesciences, IncSYRMA JOHARI MEDTECH LIMITEDQJQ2016-09-19
089080080852087E WellnessSYRMA JOHARI MEDTECH LIMITEDQJQ2016-09-19
00857869005253Alpha-Stim MElectromedical Products International, Inc.QJQ2015-11-30
00857869005260Alpha-Stim AIDElectromedical Products International, Inc.QJQ2015-11-30
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
00857869005000Alpha-Stim MElectromedical Products International, Inc.QJQ2014-08-25
00857869005017Alpha-Stim AIDElectromedical Products International, Inc.QJQ2014-08-25
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