FDA.reportPublic FDA data

Alpha-Stim Earclip Electrode (M)

Primary DI
00857869005147
Brand
Alpha-Stim Earclip Electrode (M)
Company
Electromedical Products International, Inc.
Model
Earclip Electrode (M)
Device description
Alpha-Stim Earclip Electrode (M)
Published
2014-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857869005147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857869005147008578690051478578690051470857869005147

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
00810140062680RENPHOJoicom CorporationGZJ2025-10-20
00810140062697RENPHOJoicom CorporationGZJ2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.GZJ2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.GZJ2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.GZJ2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.GZJ2025-09-11
00810113683379DualPulse CompactManamed, Inc.GZJ2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.GZJ2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.GZJ2025-08-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
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14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00810113683218ManaMedManamed, Inc.GZJ2024-04-30
B786SBM1AB0110actiTENSSUBLIMEDGZJ2024-04-24
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
B731P12T109TrueReliefTruerelief, LLCGZJ2024-01-08
00815290019409ePower® T1 TENS UNITCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17