Modius Sleep

Primary DI
05070002841203
Brand
Modius Sleep
Company
NEUROVALENS LIMITED
Model
MS1000
Device description
Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia in adults. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS). It consists of a battery-powered device designed to deliver low-level electrical energy to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads that placed on the skin behind each ear.
Published
2025-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
K230826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230826000Modius SleepNeurovalens , Ltd.2023-10-27QJQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05070002841203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05070002841203050700028412035070002841203

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219363473
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05070002841210Modius CalmMA15002025-04-04

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
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