Submission Details
| 510(k) Number | K062402 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 17, 2006 |
| Decision Date | September 21, 2006 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
K062402 is an FDA 510(k) clearance for the EASYSTAND EVOLV, a Chair, Positioning, Electric (Class II — Special Controls, product code INO), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on September 21, 2006, 35 days after receiving the submission on August 17, 2006. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3110.
| 510(k) Number | K062402 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 17, 2006 |
| Decision Date | September 21, 2006 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INO — Chair, Positioning, Electric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.3110 |