K202937 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702. 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 March 18, 2021, 169 days after receiving the submission on September 30, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.
| 510(k) Number | K202937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2020 |
| Decision Date | March 18, 2021 |
| Days to Decision | 169 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 |