FDA.reportPublic FDA data

Calm Ultra

Primary DI
M750AR636B0
Brand
Calm Ultra
Company
NEURO-FITNESS LLC
Model
AR635A
Catalog number
Calm Ultra
Device description
Cranial Electrotherapy Stimulator
Published
2026-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
M750AR636B0PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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