TENSPRODUCTS
GUDID 20816924020680
2" X 2" SQUARE WHITE CLOTH ELECTRODE 4/PK
TENSPRODUCTS, INC.
Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use| Primary Device ID | 20816924020680 |
| NIH Device Record Key | 36d0db67-f91e-402f-9d2c-2c37dc88c8a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TENSPRODUCTS |
| Version Model Number | TWC22 |
| 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 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| sales@tensproducts.com | |
| Phone | 1-866-449-1010 |
| 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 | 00816924020686 [Primary] |
| GS1 | 10816924020683 [Package] Contains: 00816924020686 Package: Inner box [50 Units] In Commercial Distribution |
| GS1 | 20816924020680 [Package] Contains: 00816924020686 Package: Case [400 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132588
FDA Product Code
| GXY | Electrode, Cutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-13 |
| Device Publish Date | 2018-07-12 |
On-Brand Devices [TENSPRODUCTS]
| 20816924020697 | 2" X 4" RECTANGLE WHITE CLOTH ELECTRODE 4/PK |
| 20816924020680 | 2" X 2" SQUARE WHITE CLOTH ELECTRODE 4/PK |
Trademark Results [TENSPRODUCTS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENSPRODUCTS 90658538 not registered Live/Pending |
Tensproducts, LLC 2021-04-20 |
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