| 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 |
| 00092237626924 - TheraTouch SW1 | 2025-05-06 Shockwave SR 15mm Applicator, Steel Round |
| 00092237626931 - TheraTouch SW1 | 2025-05-06 Shockwave SR 20mm Applicator, Steel Round |
| 00092237626948 - TheraTouch SW1 | 2025-05-06 Shockwave SR 35mm Applicator, Steel Round |
| 00092237626979 - TheraTouch SW1 | 2025-05-06 Shockwave CR 35mm Applicator, Compound Round |
| 00092237626887 - TheraTouch SW1 | 2025-04-14 SW1 WIRED HANDPIECE |
| 00092237626955 - TheraTouch SW1 | 2025-04-14 Shockwave CR 15mm Applicator |
| 00092237626962 - TheraTouch SW1 | 2025-04-14 Shockwave CR 20mm Applicator |
| 00092237626764 - TheraTouch SW1 | 2025-04-04 TheraTouch SW1 Portable Shockwave |