K220572 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. (Cheonan-Si, KR). The FDA issued a Cleared decision on June 17, 2022, 109 days after receiving the submission on February 28, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.
| 510(k) Number | K220572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2022 |
| Decision Date | June 17, 2022 |
| Days to Decision | 109 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 |