K243644 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302). 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 January 8, 2025, 43 days after receiving the submission on November 26, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.
| 510(k) Number | K243644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2024 |
| Decision Date | January 08, 2025 |
| Days to Decision | 43 days |
| Submission Type | Special |
| 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 |