TENSPRODUCTS/TENSTRODE

GUDID 20816924020321

2" X 2" SQUARE TAN CLOTH ELECTRODE POLY BAG 4/PK

TENSPRODUCTS, INC.

Transcutaneous electrical stimulation electrode
Primary Device ID20816924020321
NIH Device Record Keya7897b79-be82-4482-afa2-1b481b1b2796
Commercial Distribution StatusIn Commercial Distribution
Brand NameTENSPRODUCTS/TENSTRODE
Version Model NumberKWTS22-TP
Company DUNS121251883
Company NameTENSPRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100816924020327 [Primary]
GS100816924020334 [Package]
Contains: 00816924020327
Package: Inner bag [10 Units]
In Commercial Distribution
GS110816924020324 [Package]
Contains: 00816924020327
Package: Inner box [50 Units]
In Commercial Distribution
GS120816924020321 [Package]
Contains: 00816924020327
Package: Case [400 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-13
Device Publish Date2018-07-12

On-Brand Devices [TENSPRODUCTS/TENSTRODE]

208169240203212" X 2" SQUARE TAN CLOTH ELECTRODE POLY BAG 4/PK
308169240202293" ROUND TAN CLOTH ELECTRODE 4/PK
308169240202052" X 3.5" RECTANGLE TAN CLOTH ELECTRODE 4/PK
308169240201992" X 2" SQUARE TAN CLOTH ELECTRODE 4/PK
308169240201822" ROUND TAN CLOTH ELECTRODE 4/PK
308169240201751.25" ROUND TAN CLOTH ELECTRODE 4/PK
308169240201511.75" X 3.75" RECTANGLE BLUE GEL PREWIRED ELECTRODE 4/PK
008169240201431.75" X 1.75" SENSITIVE SKIN BLUE GEL PREWIRED ELECTRODE 4/PK
308169240201371.5" X 1.5" SQUARE TAN CLOTH ELECTRODE 4/PK
308169240201204" X 6" BUTTERFLY WHITE FOAM ELECTRODE 1/PK
308169240200832" X 2" SQUARE WHITE FOAM ELECTRODE 4/PK
308169240200762" ROUND WHITE FOAM ELECTRODE 4/PK
2081692402006213" X 1.5" BACK STRAP WHITE FOAM ELECTRODE 1/PK
208169240200481.5" x 2.5" OVAL WHITE FOAM ELECTRODE 4/PK
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.