K241193 is an FDA 510(k) clearance for the AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.). This device is classified as a Table, Physical Therapy, Multi Function (Class II - Special Controls, product code JFB).
Submitted by Marzzan Lucas Jorge (Rosario, AR). The FDA issued a Cleared decision on January 31, 2025, 277 days after receiving the submission on April 29, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.
| 510(k) Number | K241193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2024 |
| Decision Date | January 31, 2025 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | JFB - Table, Physical Therapy, Multi Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5880 |