K250266 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager (CGM MB-2401). This device is classified as a Table, Physical Therapy, Multi Function (Class II - Special Controls, product code JFB).
Submitted by Ceragem Co., Ltd. (Cheonan-Si, KR). The FDA issued a Cleared decision on July 11, 2025, 162 days after receiving the submission on January 30, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.
| 510(k) Number | K250266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2025 |
| Decision Date | July 11, 2025 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | JFB - Table, Physical Therapy, Multi Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5880 |