Device
Genesis Sleep is a non-invasive transdermal neurostimulation device to treat chronic insomnia. The device utilizes a technology known as electrical vestibular nerve stimulation (Ve...
Manufacturer
Neurofield, Inc.
Neurofield, Inc.
Model: 104
DI: 00860010064634
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3cdb1bb2-845a-4fb2-a856-08b94dac4622
Distribution Status:
In Commercial Distribution
DUNS Number:
948497578
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860010064634
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61022
Name: Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Definition:
An 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.
FDA Product Codes
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Premarket Submissions
Submission Number:
K252951
Supplement Number:
000