Genesis

Primary DI
00860010064634
Brand
Genesis
Company
Neurofield, Inc.
Model
104
Device description
Genesis Sleep is a non-invasive transdermal neurostimulation device to treat chronic insomnia. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS). It is indicated for clinical- and home-use to treat chronic insomnia in adults aged 22 and older.It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1 mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two single-use self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area).The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse which stimulates the vestibular nerve.When the device is not being used, the battery can be charged using the charging station provided. Therefore, it is not physically possible to recharge the battery while the device is in use in stimulation mode.The Genesis Sleep device exerts its therapeutic effect through electrical stimulation of the vestibular nerves. Electrical vestibular nerve stimulation (VeNS) is a non-invasive therapeutic method that applies pulsed, alternating microcurrent transcutaneously to the vestibular nerves via stimulation pads.Genesis Sleep delivers this neurostimulation through two self-adhesive stimulation pads which are placed on the skin behind each ear (mastoid processes). When turned on, the device delivers a small electrical impulse which can be adjusted up or down by the user.
Published
2026-05-07
Public version status
New
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
K252951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252951000Genesis SleepNeurofield, Inc.2025-12-31QJQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010064634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010064634008600100646348600100646340860010064634

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.

Regulatory Flags#

DUNS number
948497578
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860410000379Q211692025-06-02
00860410000300NeuroField X3000172016-08-25
00086041000030NeuroField X3000172016-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M750AR635A2Calm UltraNEURO-FITNESS LLCQJQ2026-05-21
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