CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR— 510(k) K080385
Substantially EquivalentE1 Ent., Inc.
FDA 510(k) clearance K080385 for CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR, Substantially Equivalent on 2008-05-13. Applicant: E1 Ent., Inc.. Device class: 2.
Clearance details
- Applicant
- E1 Ent., 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
- Traditional
- Location
- Pompano Beach, 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.