K992545 is an FDA 510(k) clearance for the TM-300 TRACTION SYSTEM. This device is classified as a Equipment, Traction, Powered (Class II - Special Controls, product code ITH).
Submitted by Ito Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on September 1, 1999, 33 days after receiving the submission on July 30, 1999.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5900.
| 510(k) Number | K992545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1999 |
| Decision Date | September 01, 1999 |
| Days to Decision | 33 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 |