K243355 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager (CGM-MB-1902). This device is classified as a Table, Physical Therapy, Multi Function (Class II - Special Controls, product code JFB).
Submitted by Ceragem Co., Ltd. (Chennan-Si, KR). The FDA issued a Cleared decision on November 27, 2024, 29 days after receiving the submission on October 29, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.
| 510(k) Number | K243355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2024 |
| Decision Date | November 27, 2024 |
| Days to Decision | 29 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 |