K040031 is an FDA 510(k) clearance for the CERAGEM-C THERMAL ACUPRESSURE MASSAGER. This device is classified as a Table, Physical Therapy, Multi Function (Class II - Special Controls, product code JFB).
Submitted by Ceragem Co., Ltd. (Washington, US). The FDA issued a Cleared decision on July 28, 2004, 202 days after receiving the submission on January 8, 2004.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.
| 510(k) Number | K040031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2004 |
| Decision Date | July 28, 2004 |
| Days to Decision | 202 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 |