K242754 is an FDA 510(k) clearance for the ZT Clinic (MG675A). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Zamar Medical D.O.O. (Vrsar, HR). The FDA issued a Cleared decision on May 5, 2025, 235 days after receiving the submission on September 12, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K242754 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2024 |
| Decision Date | May 05, 2025 |
| Days to Decision | 235 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |