FDA.reportPublic FDA data

510(k) K252951

Device
Genesis Sleep
Applicant
Neurofield, Inc.
510(k) number
K252951
Product code
QJQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-31
Date received
2025-09-16
Regulation
882.5800
Classification name
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Nicholas Dogris
Address
1836 St.Ate St. Santa Barbara CA US 93101 93101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QJQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232253Modius StressNeurovalens Limited2024-03-27
K230826Modius SleepNeurovalens , Ltd.2023-10-27
K182311CervellaInnovative Neurological Devices, LLC2019-03-07
K090052CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/CJohari Digital Healthcare , Ltd.2009-05-29
K070412ELEXOMA MEDICRedplane AG2008-05-21
K062284CES ULTRANeuro-Fitness, LLC2007-04-05
K060158NET-2000 MICROCURRENT STIMULATORAuri-Stem Medical, Inc.2006-10-13
K024377TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1Kalaco Scientific, Inc.2003-07-21
K932050NH-2002New Horizon Health Care1995-06-05
K903014ALPHA-STIM CSElectromedical Products, Inc.1992-05-12
K910616LB-2000 CRANIAL ELECTROTHERAPY STIMULATORLife Balance Intl., Inc.1992-05-12
K903654LISS CRANIAL STIMULATOR MODEL SBL202-BMedical Consultants Intl. , Ltd.1990-10-04
K894515LISS CRANIAL STIMULATOR MODEL SBL201-MMedical Consultants Intl. , Ltd.1990-05-03
K895175NF-1 MINDPEACENeurofitness1989-11-08
K894097NTI-1000Neurotek, Inc.1989-09-25