VICTORY THREE WHEEL SCOOTER, MODEL: SC610— 510(k) K072165
Substantially EquivalentPride Mobility Products Corp.
FDA 510(k) clearance K072165 for VICTORY THREE WHEEL SCOOTER, MODEL: SC610, Substantially Equivalent on 2007-08-17. Applicant: Pride Mobility Products Corp.. Device class: 2.
Clearance details
- Applicant
- Pride Mobility Products Corp.
- Product code
- Code INI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3800
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Exeter, PA, US
Recent devices under product code INI
view allMore clearances from Pride Mobility Products Corp.
view allAdverse events under product code INI
product code INI- Injury
- 171
- Other
- 1
- Total
- 172
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K072165
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072165.
Data sourced from openFDA. This site is unofficial and independent of the FDA.