FDA.reportPublic FDA data

TENSPRODUCTS/TENSTRODE

Primary DI
00816924020136
Brand
TENSPRODUCTS/TENSTRODE
Company
Tensproducts, LLC
Model
4040TC
Catalog number
4040TC-TP, 4040TC-MFR, 4040TC-JETT
Device description
"1.5"" X 1.5"" SQUARE TAN CLOTH ELECTRODE 4/PK"
Published
2018-07-12
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
00816924020365PackageGS110In Commercial Distribution
10816924020133PackageGS150In Commercial Distribution
30816924020137PackageGS1400In Commercial Distribution
00816924020136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816924020365008169240203658169240203650816924020365
1081692402013310816924020133
3081692402013730816924020137
00816924020136008169240201368169240201360816924020136

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-866-449-1010sales@tensproducts.com

Regulatory Flags#

DUNS number
104307787
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816924020235PRECISION TENS 3900TENS3900V2TENS3900V2, TENS3900-JETT, TENS3900-TP2019-11-21
00816924020242COMFYCOMBPLUSCOMFYCOMBOPLUSCOMFYCOMBOPLUS, COMFYCOMBOPLUS-JETT, COMFYCOMBOPLU2019-11-21
00816924020259COMFYEMSCOMFYEMSCOMFYEMS, COMFYEMS-JETT, COMFYEMS-TP, COMFYEMS-MFR2019-11-21
00816924020266COMFYTENSCOMFYTENSCOMFYTENS, COMFYTENS-JETT, COMFYTENS-TP, COMFYTENS2019-11-21
00816924020273PRECISION EMS 6.0EMS6.0EMS6.0, EMS6.0-TP, EMS6.0-MFR2019-11-21
00816924020280TETRATETRATETRA, TETRA-TP2019-11-21
00816924020297TRUTENSTRUTENSV2TRUTENSV22019-11-21
00816924020303PREMIER COMBO PLUSPREMCOMBOPLUSV2PREMCOMBOPLUSV2, PREMCOMBOPLUS-TP2019-11-21
B1900681StemWearPLB054-20302021-09-15
B1900691StemWearPLB054-30500692021-09-15
B1900700StimWearPLB054-30202021-09-15
B1900710StemWearPBL054-30220712021-09-15
B1900720StemWearPLB054-30242021-09-15
B1900730StemWearPLB054-30260732021-09-15
00816924020044TENSPRODUCTS/TENSTRODEKWF125oKWF125o-TP2018-07-12
00816924020068TENSPRODUCTS/TENSTRODEKWF1315KWF1315-TP, KWF1315-MFR2018-07-12
00816924020075TENSPRODUCTS/TENSTRODEKWF2KWF2-TP2018-07-12
00816924020082TENSPRODUCTS/TENSTRODEKWF22KWF22-TP2018-07-12
00816924020129TENSPRODUCTS/TENSTRODEKWF46KWF46-TP, KWF46-MFR, KWF46-JETT2018-07-12
00816924020150TENSPRODUCTS/TENSTRODEBWT13BWT13-TP, BWT13-MFR2018-07-12

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