Calm Ultra

Primary DI
M750AR635A2
Brand
Calm Ultra
Company
NEURO-FITNESS LLC
Model
AR635A
Catalog number
Calm Ultra
Device description
Cranial Electrotherapy Stimulator
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
M750AR635A2PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation systemAn 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.

Contacts#

Phone, Email table
PhoneEmail
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
M750AR635A1CES-UltraAR635ACES-Ultra2017-02-12
M750AR635A0CES-UltraAR635ACES-Ultra2017-06-30
M750AR635ACES-UltraAR635ACES-Ultra2017-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010064634GenesisNeurofield, Inc.QJQ2026-05-07
05070002841210Modius CalmNEUROVALENS LIMITEDQJQ2025-04-04
05070002841203Modius SleepNEUROVALENS LIMITEDQJQ2025-01-23
08908008085383Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDQJQ2020-10-30
08908008085314Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDQJQ2019-04-30
089080080853217E WellnessSYRMA JOHARI MEDTECH LIMITEDQJQ2019-04-30
M750AR635A0CES-UltraNEURO-FITNESS LLCQJQ2017-06-30
M750AR635A1CES-UltraNEURO-FITNESS LLCQJQ2017-02-12
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
00857869005000Alpha-Stim MElectromedical Products International, Inc.QJQ2014-08-25
00857869005017Alpha-Stim AIDElectromedical Products International, Inc.QJQ2014-08-25