The following data is part of a premarket notification filed by Ceragem Co., Ltd. with the FDA for Ceragem-c Thermal Acupressure Massager.
| Device ID | K040031 |
| 510k Number | K040031 |
| Device Name: | CERAGEM-C THERMAL ACUPRESSURE MASSAGER |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | CERAGEM CO., LTD. 1800 MASSACHUSETTS AVE., NW SUITE 200 Washington, DC 20036 -1221 |
| Contact | Suzan Onel |
| Correspondent | Suzan Onel CERAGEM CO., LTD. 1800 MASSACHUSETTS AVE., NW SUITE 200 Washington, DC 20036 -1221 |
| Product Code | JFB |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-08 |
| Decision Date | 2004-07-28 |
| Summary: | summary |