GRAF CORELLO, POWERED WHEELCHAIR— 510(k) K863407

Substantially Equivalent

Graf Products, Inc.

FDA 510(k) clearance K863407 for GRAF CORELLO, POWERED WHEELCHAIR, Substantially Equivalent on 1986-09-23. Applicant: Graf Products, Inc..

Clearance details

Applicant: Graf Products, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1986-09-03
Decision date: 1986-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, 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.