TENSPRODUCTS/TENSTRODE KWTS235-TP, KWTS235-MFR, KWTS235-JETT

GUDID 30816924020205

2" X 3.5" RECTANGLE TAN CLOTH ELECTRODE 4/PK

TENSPRODUCTS, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 30816924020205
• NIH Device Record Key: 171b8df1-047e-48bf-91d0-8fda5d604743
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TENSPRODUCTS/TENSTRODE
• Version Model Number: KWTS235
• Catalog Number: KWTS235-TP, KWTS235-MFR, KWTS235-JETT
• Company DUNS: 121251883
• Company Name: TENSPRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com
• Phone: 1-866-449-1010
• Email: sales@tensproducts.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816924020204 [Primary]
GS1	10816924020201 [Package]; Contains: 00816924020204; Package: Inner box [30 Units]; In Commercial Distribution
GS1	30816924020205 [Package]; Contains: 00816924020204; Package: Case [240 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012463

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-21
• Device Publish Date: 2018-07-12

On-Brand Devices [TENSPRODUCTS/TENSTRODE]

• 20816924020321: 2" X 2" SQUARE TAN CLOTH ELECTRODE POLY BAG 4/PK
• 30816924020229: 3" ROUND TAN CLOTH ELECTRODE 4/PK
• 30816924020205: 2" X 3.5" RECTANGLE TAN CLOTH ELECTRODE 4/PK
• 30816924020199: 2" X 2" SQUARE TAN CLOTH ELECTRODE 4/PK
• 30816924020182: 2" ROUND TAN CLOTH ELECTRODE 4/PK
• 30816924020175: 1.25" ROUND TAN CLOTH ELECTRODE 4/PK
• 30816924020151: 1.75" X 3.75" RECTANGLE BLUE GEL PREWIRED ELECTRODE 4/PK
• 00816924020143: 1.75" X 1.75" SENSITIVE SKIN BLUE GEL PREWIRED ELECTRODE 4/PK
• 30816924020137: 1.5" X 1.5" SQUARE TAN CLOTH ELECTRODE 4/PK
• 30816924020120: 4" X 6" BUTTERFLY WHITE FOAM ELECTRODE 1/PK
• 30816924020083: 2" X 2" SQUARE WHITE FOAM ELECTRODE 4/PK
• 30816924020076: 2" ROUND WHITE FOAM ELECTRODE 4/PK
• 20816924020062: 13" X 1.5" BACK STRAP WHITE FOAM ELECTRODE 1/PK
• 20816924020048: 1.5" x 2.5" OVAL WHITE FOAM ELECTRODE 4/PK