| Primary Device ID | 00092237626924 |
| NIH Device Record Key | 136ef0e5-ccc2-4f1d-b4af-ac7b465ef238 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TheraTouch SW1 |
| Version Model Number | SR15-APP |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00092237626924 [Primary] |
| ISA | Massager, Therapeutic, Electric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-06 |
| Device Publish Date | 2025-04-28 |
| 00092237626764 | TheraTouch SW1 Portable Shockwave |
| 00092237626962 | Shockwave CR 20mm Applicator |
| 00092237626955 | Shockwave CR 15mm Applicator |
| 00092237626887 | SW1 WIRED HANDPIECE |
| 00092237626979 | Shockwave CR 35mm Applicator, Compound Round |
| 00092237626948 | Shockwave SR 35mm Applicator, Steel Round |
| 00092237626931 | Shockwave SR 20mm Applicator, Steel Round |
| 00092237626924 | Shockwave SR 15mm Applicator, Steel Round |
| 00092237626894 | SW1 BATTERY MODULE |