| K-number | K230037 |
| Device name | BACK 3 |
| Applicant | Swims America Corp |
| Product code | PBX |
| Device class | Class II |
| Decision date | Jul 19, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 878.4400 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov