K072534 is an FDA 510(k) clearance for the BIO-MAT 2000. This device is classified as a Pad, Heating, Powered (Class II - Special Controls, product code IRT).
Submitted by Richway Intl., Inc. (Honolulu, US). The FDA issued a Cleared decision on February 8, 2008, 154 days after receiving the submission on September 7, 2007.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5740.
| 510(k) Number | K072534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2007 |
| Decision Date | February 08, 2008 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRT — Pad, Heating, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5740 |