The following data is part of a premarket notification filed by Ceragem Co, Ltd. with the FDA for Ceragem Automatic Thermal Massager, Model Cgm-mb-1901.
| Device ID | K202113 |
| 510k Number | K202113 |
| Device Name: | Ceragem Automatic Thermal Massager, Model CGM-MB-1901 |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | Ceragem Co, Ltd. 10, Jeongja 1-Gil, Seonggeo-Eup, Seobuk-Gu Cheonan-si, KR 31041 |
| Contact | Hyeonggeun Hwang |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, CA 92620 |
| Product Code | JFB |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-30 |
| Decision Date | 2021-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809494000075 | K202113 | 000 |