| Primary Device ID | 80092237617508 |
| NIH Device Record Key | 19358a2a-e383-4ebb-91b0-ee1956e10351 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TENS PROS |
| Version Model Number | WW8000-TP |
| Company DUNS | 827221698 |
| Company Name | COMPASS HEALTH BRANDS CORP. |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00092237617502 [Primary] |
| GS1 | 01092237617501 [Unit of Use] |
| GS1 | 80092237617508 [Package] Contains: 00092237617502 Package: CA [500 Units] In Commercial Distribution |
| IKD | Cable, Electrode |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-13 |
| 80092237617508 | Lead Wires for Neo Tek Devices |
| 30092237626260 | TENS Pro Classic 2-Go Electrodes, 2" x 2" Square, white cloth |
| 30092237626253 | TENS Pro Gold Electrodes, 4" x 6" Butterfly shape, white foam |
| 30092237626246 | TENS Pro Gold Electrodes, 2" x 3.5" Rectangle, Tan cloth, foil bag |
| 30092237626239 | TENS Pro Gold Electrodes, 2" x 2" Square, Tan cloth, foil bag |
| 30092237626222 | TENS Pro Gold Electrodes, 1.5" x 14" Low back strip, white foam |
| 30092237626215 | TENS Pros Classic Electrodes, 2" x 3.5" rectangle, white cloth |
| 00092237626207 | TENS Pros Classic Electrodes - 2" x 2" Square, White Cloth, Poly Bag |