JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II— 510(k) K031342
Substantially EquivalentJason Marine Enterprises, Inc.
FDA 510(k) clearance K031342 for JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II, Substantially Equivalent on 2003-07-10. Applicant: Jason Marine Enterprises, Inc..
Clearance details
- Applicant
- Jason Marine Enterprises, Inc.
- Product code
- Code ITI
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Coral Springs, FL, US
Adverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
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.