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510(k) K932050

Device
Nh-2002
Applicant
NEW HORIZON HEALTH CARE
510(k) number
K932050
Product code
QJQ
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-05
Date received
1993-04-27
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
DALE DENSLEY
Address
9127 S. 255 W. Sandy UT US 84092 84092

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code QJQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252951Genesis SleepNeurofield, Inc.2025-12-31
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
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