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.. Device class: 2.
Clearance details
- Applicant
- Jason Marine Enterprises, Inc.
- Product code
- Code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Coral Springs, FL, US
Recent devices under product code ITI
view allAdverse 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.