neurofield.orgNeuroField Analysis Suite
Neurofield, Inc.
NEUROFIELD, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010900508 | 3010900508 | NEUROFIELD, INC. | 1 | N | 2026-01-01 | 1836 State St Santa Barbara CA US 93101 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00086041000030 | NeuroField X3000 - Pulsed Electromagnetic Field (pEMF) generator for use with NeuroField Software Suite. Stimulation unit for low-intensity neurofeedback. | 7608724200 | contact@neurofield.org |
| 00860410000300 | NeuroField X3000 - Pulsed Electromagnetic Field (pEMF) generator for use with NeuroField Software Suite. Stimulation unit for low-intensity neurofeedback. | 7608724200 | contact@neurofield.org |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 171843 | 1714528783 | K252951 | Genesis Sleep | QJQ | 2025-12-31 |
| 171843 | 1165650641 | K240420 | NeuroField Analysis Suite | OLU | 2024-09-20 |
| 171843 | 1424132186 | K221959 | Q21 | GWQ | 2023-08-31 |
| 171843 | 1156372295 | ||||
| 171843 | 1227600217 |
Product Codes Associated With Registrations#
PMN#
Q21
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.
2026-05-07
Q21 - The Q21 is a 19 channel EEG amplifier with a low noise floor of 0.25 microvolts peak to peak from 0.1 to 10.0Hz, meaning that you can record brain wave data without worrying about noise contamination. On top of our low-noise design, the Q21 is a non-multiplexed, multi-channel readout amp, minimizing slew for the most accurate whole brain imaging, and giving you the exact readout of your EEG recordings, with no loss of data or smoothing.
2025-06-02
NeuroField X3000 - Pulsed Electromagnetic Field (pEMF) generator for use with NeuroField Software Suite. Stimulation unit for low-intensity neurofeedback.
2016-08-25
NeuroField X3000 - Pulsed Electromagnetic Field (pEMF) generator for use with NeuroField Software Suite. Stimulation unit for low-intensity neurofeedback.
2016-08-25