| 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 |
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| 00815067013081 - Probasics | 2025-07-29 K4 Deluxe Single Arm Drive Hardware Included |
| 00815067013098 - Probasics | 2025-07-29 K4 Deluxe Amputee Adapter Hardware Included |
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| 30092237628561 - TENS 7000 | 2025-07-18 TENS 7000 Migraine Pads 4 Ct |
| 00813520010141 - Roscoe Medical | 2025-07-11 ELECTRODE - FOIL - 2" x 3.5" - WHITE FOAM |
| 00813520010493 - Roscoe Medical | 2025-07-11 Electrode - Foil - 2x3.5 - |