FDA.reportPublic FDA data

"Protekt Titanium Adhesive Pre-Gelled Electrode for TENS - Rectangular 2""x4"""

Primary DI
05060488570964
Brand
"Protekt Titanium Adhesive Pre-Gelled Electrode for TENS - Rectangular 2""x4"""
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
PMTENSEL2
Catalog number
PMTENSEL2
Device description
"Protekt Titanium Adhesive Pre-Gelled Electrode for TENS - Rectangular 2""x4"""
Published
2020-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K012463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012463000LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVALEveryway Medical Instruments Co.,Ltd2002-02-05GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488570964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488570964050604885709645060488570964

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1Inch
Length4Inch
Width6Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 855 237 7622sales@proactivemedical.com

Regulatory Flags#

DUNS number
078582655
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05061105057455Protekt VX 5000PMVSM5000PMVSM50002025-12-18
05060488573293Protekt PartsPP-AHDAASMK3LFTPP-AHDAASMK3LFT2022-11-18
05060488573309Protekt PartsPP-AHDAASMK3RTPP-AHDAASMK3RT2022-11-18
05060488573316Protekt PartsPP-AHFAASMK3LFTPP-AHFAASMK3LFT2022-11-18
05060488573323Protekt PartsPP-AHFAASMK3RTPP-AHFAASMK3RT2022-11-18
05060488572401Protekt LiftPL400HPL400H2022-05-11
05060488570902Procure Nebulizer002-102785002-1027852020-01-01
05060488570926Procure Blood Pressure Monitor, Digital, Auto Inflate w/ Batteries002-102738002-1027382020-01-01
05060488570162Protekt Aire94001940012016-08-12
05060488570179Protekt Aire94003940032016-08-12
05060488570186Protekt Aire94004940042016-08-12
05060488570452Protekt Aire Replacement Pump80091800912016-08-12
05060488570490Protekt Aire Replacement Mattress80032800322016-08-12
05060488570506Protekt Aire Replacement Mattress80042800422016-08-12
05060488570544Protekt Aire Replacement Mattress80082800822016-08-12
05060488570551Protekt Aire Replacement Mattress80087800872016-08-12
05060488570728Protekt Aire83500835002018-03-07
05060488570735Protekt Aire83600836002018-03-07
05060488570742Protekt Aire84600846002018-03-07
05060488570773Protekt Aire81090-42B81090-42B2018-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
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