MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS— 510(k) K032731

Substantially Equivalent

Turbo Wheelchair Co., Inc.

FDA 510(k) clearance K032731 for MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS, Substantially Equivalent on 2003-10-30. Applicant: Turbo Wheelchair Co., Inc..

Clearance details

Applicant: Turbo Wheelchair Co., Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2003-09-03
Decision date: 2003-10-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Beaufort, SC, US

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.