Submission Details
| 510(k) Number | K030814 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2003 |
| Decision Date | March 20, 2003 |
| Days to Decision | 6 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
K030814 is an FDA 510(k) clearance for the INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3, a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on March 20, 2003, 6 days after receiving the submission on March 14, 2003. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K030814 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2003 |
| Decision Date | March 20, 2003 |
| Days to Decision | 6 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INI — Vehicle, Motorized 3-wheeled |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.3800 |