K112074 is an FDA 510(k) clearance for the EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800. This device is classified as a Equipment, Traction, Powered (Class II - Special Controls, product code ITH).
Submitted by Everyway Medical Instruments Co.,Ltd (Roswell, US). The FDA issued a Cleared decision on February 1, 2012, 196 days after receiving the submission on July 20, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5900.
| 510(k) Number | K112074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2011 |
| Decision Date | February 01, 2012 |
| Days to Decision | 196 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 |