FDA.reportPublic FDA data

TENSPRODUCTS/TENSTRODE

Primary DI
30816924020137
Brand
TENSPRODUCTS/TENSTRODE
Company
TENSPRODUCTS, INC.
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
Rx
false
OTC
false
Sterile
false
Single use
false

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 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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
121251883
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816924020232PRECISION TENS 3900TENS3900V2TENS3900V2, TENS3900-JETT, TENS3900-TP2019-11-21
10816924020249COMFYCOMBPLUSCOMFYCOMBOPLUSCOMFYCOMBOPLUS, COMFYCOMBOPLUS-JETT, COMFYCOMBOPLU2019-11-21
10816924020256COMFYEMSCOMFYEMSCOMFYEMS, COMFYEMS-JETT, COMFYEMS-TP, COMFYEMS-MFR2019-11-21
10816924020263COMFYTENSCOMFYTENSCOMFYTENS, COMFYTENS-JETT, COMFYTENS-TP, COMFYTENS2019-11-21
10816924020270PRECISION EMS 6.0EMS6.0EMS6.0, EMS6.0-TP, EMS6.0-MFR2019-11-21
10816924020287TETRATETRATETRA, TETRA-TP2019-11-21
10816924020294TRUTENSTRUTENSV2TRUTENSV22019-11-21
10816924020300PREMIER COMBO PLUSPREMCOMBOPLUSV2PREMCOMBOPLUSV2, PREMCOMBOPLUS-TP2019-11-21
20816924020048TENSPRODUCTS/TENSTRODEKWF125oKWF125o-TP2018-07-12
20816924020062TENSPRODUCTS/TENSTRODEKWF1315KWF1315-TP, KWF1315-MFR2018-07-12
30816924020076TENSPRODUCTS/TENSTRODEKWF2KWF2-TP2018-07-12
30816924020083TENSPRODUCTS/TENSTRODEKWF22KWF22-TP2018-07-12
30816924020120TENSPRODUCTS/TENSTRODEKWF46KWF46-TP, KWF46-MFR, KWF46-JETT2018-07-12
30816924020151TENSPRODUCTS/TENSTRODEBWT13BWT13-TP, BWT13-MFR2018-07-12
30816924020175TENSPRODUCTS/TENSTRODEKWTS125rKWTS125r-TP2018-07-12
30816924020182TENSPRODUCTS/TENSTRODEKWTS2-TPKWTS2-MFR, KWTS2-JETT2018-07-12
30816924020199TENSPRODUCTS/TENSTRODEKWTS22KWTS22-TPF, KWTS22-JETT2018-07-12
30816924020205TENSPRODUCTS/TENSTRODEKWTS235KWTS235-TP, KWTS235-MFR, KWTS235-JETT2018-07-12
30816924020229TENSPRODUCTS/TENSTRODEKWTS3KWTS3-TP, KWTS3-MFR, KWTS3-JETT2018-07-12
20816924020321TENSPRODUCTS/TENSTRODEKWTS22-TP2018-07-12

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