FDA.reportPublic FDA data

StimPatch

Primary DI
10185098000747
Brand
StimPatch
Company
PRO MEDICAL SUPPLIES, INC.
Model
Stim-030
Catalog number
Stim-030
Device description
"Electrodes White Foam Back 2.0""x4.0"" (100 Packs Per Pack = 4 Electrodes Per Pack = 400)"
Published
2016-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132998000WANDY SELF-ADHESIVE ELECTRODESWandy Rubber Industrial Co., Ltd.2013-12-20GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10185098000747PrimaryGS10
18509800074040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1018509800074710185098000747
1850980007404018509800074040

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn 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 (EMS), 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-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
215-938-0200sales@promedspecialties.com

Regulatory Flags#

DUNS number
135741127
Device count
400
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00185098000924Pro-MedProM-054RProM-054R2019-10-24
01085098000655PM-745PM-745PM-7452017-06-30
02085098000089ProPatchProM-033ProM-0332016-07-26
10185098000020ProM-200ProM-200ProM-2002016-08-24
10185098000037ProM-300ProM-300ProM-3002016-08-24
10185098000051ProM-500ProM-500ProM-5002016-08-24
10185098000068ProM-555ProM-555ProM-5552016-08-24
10185098000143ProPatchProM-036ProM-0362016-07-26
10185098000204ProPatchProM-021ProM-0212016-07-26
10185098000211ProPatchProM-032ProM-0322016-07-26
10185098000297PM-355PM-355PM-3552016-08-24
10185098000327PM-720PM-720PM-7202016-08-24
10185098000334ProPatchProM-024ProM-0242016-07-26
10185098000341Flex PlusProM-039ProM-0392016-07-26
10185098000372EcoPatchEco-020Eco-0202016-07-26
10185098000426EcoPatchEco-030Eco-0302016-07-26
10185098000433PM-360PM-360PM-3602016-08-24
10185098000440ProPatchProM-037ProM-0372016-07-26
10185098000631EcoPatchEco-021Eco-0212016-07-26
10185098000716StimPatchStim-021Stim-0212016-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08682250582028Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582035Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582042Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582059Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
10816312029427Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-10-27
00817717023105SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023112SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023129SENSADERM BLUEVision Quest Industries IncorporatedGXY2026-10-23
00817717023136SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07