MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33— 510(k) K020002
Substantially EquivalentTransworld Mobility Distribution, LLC
FDA 510(k) clearance K020002 for MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33, Substantially Equivalent on 2002-03-21. Applicant: Transworld Mobility Distribution, LLC. Device class: 2.
Clearance details
- Applicant
- Transworld Mobility Distribution, LLC
- 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
- Abbreviated
- Location
- Fort Myers, FL, US
Recent devices under product code INI
view allMore clearances from Transworld Mobility Distribution, LLC
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.