FDA.reportPublic FDA data

NEUROFIELD, INC.

Matched from indexed company URL: Neurofield, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30109005083010900508NEUROFIELD, INC.1N2026-01-011836 State St Santa Barbara CA US 93101

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00086041000030NeuroField X3000 - Pulsed Electromagnetic Field (pEMF) generator for use with NeuroField Software Suite. Stimulation unit for low-intensity neurofeedback.7608724200contact@neurofield.org
00860410000300NeuroField X3000 - Pulsed Electromagnetic Field (pEMF) generator for use with NeuroField Software Suite. Stimulation unit for low-intensity neurofeedback.7608724200contact@neurofield.org

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1718431714528783K252951Genesis SleepQJQ2025-12-31
1718431165650641K240420NeuroField Analysis SuiteOLU2024-09-20
1718431424132186K221959Q21GWQ2023-08-31
1718431156372295
1718431227600217

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QJQ12025-12-31
OLU12024-09-20
GWQ12023-08-31

PMN#

Q21

2023-08-31

Neurofield, Inc.

GUDID#

Genesis - 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.

Neurofield, Inc.

2026-05-07