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…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

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.

Chinese manufacturers registered for FDA product code QJQ
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

Regulatory record for Genesis
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

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Genesis
Catalogue number Size Status
104 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer