FDA.reportPublic FDA data

Nexalin

Primary DI
B788KS02001
Brand
Nexalin
Company
NEXALIN TECHNOLOGY
Model
KS02001
Catalog number
KS02001
Device description
Patient cable for transcranial electrical stimulation (TES)
Published
2019-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JXKStimulator, Cranial Electrotherapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXKCranial Electrotherapy Stimulator To Treat DepressionNeurology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024377000TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1Kalaco Scientific, Inc.2003-07-21QJQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B788KS02001PrimaryHIBCC0
00860008546029SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008546029008600085460298600085460290860008546029

GMDN Terms#

Term, Definition table
TermDefinition
Transcranial electrical stimulation system, continuous-current, professionalA noninvasive assembly of electrically-powered devices designed to apply weak continuous (not pulsed) electrical current (typically up to 2 mA) across the skin to a patient's brain as a therapy for one or more psychiatric/neurological indications such as depression, neuropathic pain, speech rehabilitation, motor skills recovery after stroke, and auditory hallucinations in schizophrenia. It is intended to be used within a healthcare facility for one or more therapy types [e.g., transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS)]. It includes a current generator, cables, scalp electrodes, and may include additional accessories.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
091477825
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008546005Nexalin ADIDXD 00802026-03-16
B788KS02000NexalinKS02000KS020002019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857869005277Alpha-Stim Conducting SolutionElectromedical Products International, Inc.JXK2021-11-30
00857869005284Alpha-Stim Conducting SolutionElectromedical Products International, Inc.JXK2021-11-30
08908008085406Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDJXK2021-03-12
B788KS02000NexalinNEXALIN TECHNOLOGYJXK2019-10-01
00860001493306CervellaINNOVATIVE NEUROLOGICAL DEVICES LLCJXK2019-04-30
08908008085314Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDJXK2019-04-30
089080080853217E WellnessSYRMA JOHARI MEDTECH LIMITEDJXK2019-04-30
M750AR635A0CES-UltraNEURO-FITNESS LLCJXK2017-06-30
M750AR635ACES-UltraNEURO-FITNESS LLCJXK2017-02-12
00857869005239TruDenta Earclip Electrode PadElectromedical Products International, Inc.JXK2015-06-30
00857869005161Alpha-Stim Earclip Electrode (M)Electromedical Products International, Inc.JXK2014-08-29
00857869005178Alpha-Stim Earclip Electrode (AID)Electromedical Products International, Inc.JXK2014-08-29
00857869005031Alpha-Stim Earclip Electrode PadElectromedical Products International, Inc.JXK2014-08-25
00857869005079Alpha Conducting SolutionElectromedical Products International, Inc.JXK2014-08-25
00857869005086Alpha Conducting Solution Electromedical Products International, Inc.JXK2014-08-25
00857869005093Alpha-Stim Earclip Electrode (CE3)Electromedical Products International, Inc.JXK2014-08-25
00857869005130Alpha-Stim Earclip Electrode (AID)Electromedical Products International, Inc.JXK2014-08-25