TENSTRODE KWTS22-MFR
GUDID 30850209007000
2" X 2" SQUARE TAN CLOTH ELECTRODE POLY BAG 4/PK
MEDICAL FINANCE RESOURCES INC
Transcutaneous electrical stimulation electrode| Primary Device ID | 30850209007000 |
| NIH Device Record Key | 9d950dd3-a11a-4fc7-843a-4f257cdd8238 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TENSTRODE |
| Version Model Number | KWTS22-MFR |
| Catalog Number | KWTS22-MFR |
| Company DUNS | 938569712 |
| Company Name | MEDICAL FINANCE RESOURCES 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 |
Operating and Storage Conditions
| 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 | 00850209007009 [Primary] |
| GS1 | 10850209007006 [Package] Contains: 00850209007009 Package: INNER BAG [10 Units] In Commercial Distribution |
| GS1 | 20850209007003 [Package] Contains: 00850209007009 Package: INNER BOX [50 Units] In Commercial Distribution |
| GS1 | 30850209007000 [Package] Contains: 00850209007009 Package: CASE [400 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-29 |
| Device Publish Date | 2019-11-21 |
Devices Manufactured by MEDICAL FINANCE RESOURCES INC
| 30850209007000 - TENSTRODE | 2019-11-292" X 2" SQUARE TAN CLOTH ELECTRODE POLY BAG 4/PK |
| 30850209007000 - TENSTRODE | 2019-11-29 2" X 2" SQUARE TAN CLOTH ELECTRODE POLY BAG 4/PK |
| 10850209007013 - Precision TENS3900 | 2019-11-29 PRECISION TENS3900 4 MODE 90mA ANALOG TENS UNIT WITH TIMER |
| 10850209007075 - ComfyComboPlus | 2019-11-29 DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS |
Trademark Results [TENSTRODE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENSTRODE 88288103 5834318 Live/Registered |
TENSPRODUCTS, INC. 2019-02-04 |
 TENSTRODE 77189620 3375512 Dead/Cancelled |
TENSPRODUCTS, INC. 2007-05-24 |
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