FDA.reportPublic FDA data

Alpha Conducting Solution

Primary DI
00857869005086
Brand
Alpha Conducting Solution
Company
Electromedical Products International, Inc.
Model
ACSR
Device description
Alpha Conducting Solution Refill 250ml
Published
2014-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JXKStimulator, Cranial Electrotherapy

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857869005086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857869005086008578690050868578690050860857869005086

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
610954729
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857869005000Alpha-Stim MM400KIT2014-08-25
00857869005017Alpha-Stim AIDAID500KIT2014-08-25
00857869005253Alpha-Stim MM400KITUS2015-11-30
00857869005260Alpha-Stim AIDAID500KITUS2015-11-30
00857869005277Alpha-Stim Conducting SolutionSL502021-11-30
00857869005284Alpha-Stim Conducting SolutionSL2502021-11-30
00857869005208Alpha-Stim SCSSCS2014-10-28
00857869005055AS-TrodesAT72014-08-25
00857869005093Alpha-Stim Earclip Electrode (CE3)Earclip Electrode (CE3)2014-08-25
00857869005130Alpha-Stim Earclip Electrode (AID)Earclip Electrode (AID)2014-08-25
00857869005147Alpha-Stim Earclip Electrode (M)Earclip Electrode (M)2014-08-25
00857869005161Alpha-Stim Earclip Electrode (M)Earclip Electrode (M) [RoHS]2014-08-29
00857869005178Alpha-Stim Earclip Electrode (AID)Earclip Electrode (AID) [RoHS]2014-08-29
00857869005215TruDenta ElectrodesTruDenta Electrodes2015-06-30
00857869005185Alpha-Stim PPMPPM2014-10-13
00857869005192Alpha-Stim 1001002014-10-28
00857869005222TruDenta MM2015-06-30
00857869005079Alpha Conducting SolutionACS2014-08-25
00857869005024Alpha-Stim Probe Electrode PadPEP2014-08-25
00857869005031Alpha-Stim Earclip Electrode PadEEP2014-08-25

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
B788KS02001NexalinNEXALIN TECHNOLOGYJXK2019-10-07
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
00857869005093Alpha-Stim Earclip Electrode (CE3)Electromedical Products International, Inc.JXK2014-08-25
00857869005130Alpha-Stim Earclip Electrode (AID)Electromedical Products International, Inc.JXK2014-08-25