K081247 is an FDA 510(k) clearance for the TM-400. This device is classified as a Equipment, Traction, Powered (Class II - Special Controls, product code ITH).
Submitted by Ito Co., Ltd. (Richardson, US). The FDA issued a Cleared decision on August 25, 2008, 116 days after receiving the submission on May 1, 2008.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5900.
| 510(k) Number | K081247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2008 |
| Decision Date | August 25, 2008 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ITH - Equipment, Traction, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5900 |