Submission Details
| 510(k) Number | K092088 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 09, 2009 |
| Decision Date | July 16, 2009 |
| Days to Decision | 7 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Special
VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713
Jul 2009
Decision
7d
Days
Class 2
Risk
About This 510(k) Submission
K092088 is an FDA 510(k) clearance for the VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713, 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 July 16, 2009, 7 days after receiving the submission on July 9, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.
Device Classification
| Product Code | INI — Vehicle, Motorized 3-wheeled |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.3800 |
Manufacturer
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