FDA.reportPublic FDA data

Alpha-Stim Conducting Solution

Primary DI
00857869005277
Brand
Alpha-Stim Conducting Solution
Company
Electromedical Products International, Inc.
Model
SL50
Device description
Alpha-Stim Conducting Solution 50 ml
Published
2021-11-30
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
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
JXKCranial Electrotherapy Stimulator To Treat Depression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
JXKCranial Electrotherapy Stimulator To Treat DepressionNeurology3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857869005274PackageGS1200In Commercial Distribution
00857869005277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085786900527410857869005274
00857869005277008578690052778578690052770857869005277

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
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
00857869005086Alpha Conducting Solution ACSR2014-08-25
00857869005024Alpha-Stim Probe Electrode PadPEP2014-08-25
00857869005031Alpha-Stim Earclip Electrode PadEEP2014-08-25

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