FDA.reportPublic FDA data

FlexPlus

Primary DI
00185098000757
Brand
FlexPlus
Company
PRO MEDICAL SUPPLIES, INC.
Model
ProM-028
Catalog number
ProM-028
Device description
"Electrodes Black Foam Back 1.75""x3.75"" (1 pack = 4 electrodes per pack)"
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
00185098000757PrimaryGS10
18509800075704Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00185098000757001850980007571850980007570185098000757
1850980007570418509800075704

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

Contacts#

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

Regulatory Flags#

DUNS number
135741127
Device count
4
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
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02