CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR— 510(k) K080385

Substantially Equivalent

E1 Ent., Inc.

FDA 510(k) clearance K080385 for CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR, Substantially Equivalent on 2008-05-13. Applicant: E1 Ent., Inc..

Clearance details

Applicant: E1 Ent., Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2008-02-13
Decision date: 2008-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pompano Beach, FL, US

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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, 2020-01-01 through 2026-04-23. 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.