The following data is part of a premarket notification filed by Ceragem International, Inc. with the FDA for Ceragem Rh1 Automatic Thermal Massager.
| Device ID | K062476 |
| 510k Number | K062476 |
| Device Name: | CERAGEM RH1 AUTOMATIC THERMAL MASSAGER |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | CERAGEM INTERNATIONAL, INC. 1601 K STREET NW Washington, DC 20006 |
| Contact | Susan Onel |
| Correspondent | Susan Onel CERAGEM INTERNATIONAL, INC. 1601 K STREET NW Washington, DC 20006 |
| Product Code | JFB |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-24 |
| Decision Date | 2006-10-31 |
| Summary: | summary |