Submission Details
| 510(k) Number | K090805 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 2009 |
| Decision Date | April 03, 2009 |
| Days to Decision | 9 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
K090805 is an FDA 510(k) clearance for the V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710, a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Pride Mobility Products Corp. (Exeter, US). The FDA issued a Cleared decision on April 3, 2009, 9 days after receiving the submission on March 25, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K090805 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 2009 |
| Decision Date | April 03, 2009 |
| Days to Decision | 9 days |
| Submission Type | Special |
| 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 |