FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50— 510(k) K063736

Substantially Equivalent

Pdg Product Design Group, Inc.

FDA 510(k) clearance K063736 for FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50, Substantially Equivalent on 2007-01-17. Applicant: Pdg Product Design Group, Inc..

Clearance details

Applicant: Pdg Product Design Group, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2006-12-18
Decision date: 2007-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.