| Primary Device ID | 00092237619605 |
| NIH Device Record Key | 0769ff35-9700-4682-8433-554d957562eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTENSITY AT HOME |
| Version Model Number | E201-6R |
| Company DUNS | 827221698 |
| Company Name | COMPASS HEALTH BRANDS CORP. |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 00092237619605 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-10 |
| Device Publish Date | 2025-01-31 |
| 00092237613269 - Roscoe Medical | 2026-03-17 TheraSonic Conductive Gel, 16oz LS5266CA |
| 00194346678921 - Equate | 2026-03-17 |
| 00714905117649 - Fab Stim | 2026-02-16 Fab Stim Analog TENS |
| 00714905710024 - Fab Stim | 2026-02-16 Fab Stim Plus - Digital TENS |
| 00860163000312 - CMS | 2026-02-16 TENS 3000 CMS |
| 00092237622209 - SCRIPHESSCO | 2026-02-11 SCRIPHESSCO BASIC ELECTRODE 2" ROUND CLOTH, 4/PK |
| 00092237622216 - SCRIPHESSCO | 2026-02-11 SCRIPHESSCO BASIC ELECTRODE 2" X 2" CLOTH, 4/PK |
| 00092237622339 - SCRIPHESSCO | 2026-02-11 SCRIPHESSCO PREMIUM ELECTRODES, 2" X 4" FOAM, 4/PK |