TENSPRODUCTS
GUDID 20816924020680
2" X 2" SQUARE WHITE CLOTH ELECTRODE 4/PK
TENSPRODUCTS, INC.
Transcutaneous electrical stimulation electrode| 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.