Genesis
Genesis Sleep is a non-invasive neurostimulation device indicated for chronic insomnia in adults aged 22 and older. The device delivers low-level electrical energy through two adhesive…
Genesis Sleep is a non-invasive neurostimulation device indicated for chronic insomnia in adults aged 22 and older.
The device delivers low-level electrical energy through two adhesive electrode pads placed on the skin behind the ears over the mastoid processes.
Listed Item
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.
Electrode Placement and Controls
The filing calls the method electrical vestibular nerve stimulation and says users can adjust pulse intensity up or down. The device charges on a provided charging station.
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hang Yik Electronics Plastics & Mold (ShenZhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| ATR (Dongguan) Electronics Manufactory | Tangxia Town, Dongguan | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Neurofield, Inc., United States |
|---|---|
| FDA product code | QJQ |
| Device type | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K252951 |
| Record published | 2026-05-07 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 104 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 7E Wellness | Syrma Johari MedTech Limited | 2 |
| Alpha-Stim M | Electromedical Products Intl., Inc. | 2 |
| Johari Digital Healthcare Ltd. | Syrma Johari MedTech Limited | 2 |
| Alpha-Stim AID | Electromedical Products Intl., Inc. | 2 |
| CES-Ultra | Neuro-Fitness LLC | 1 |
| Modius Calm | Neurovalens | 1 |
| Solace Lifesciences, Inc | Syrma Johari MedTech Limited | 1 |
| Modius Sleep | Neurovalens | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252951 | 2025-12-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.