REGAL MOTOTRIZED 3 WHEELED VEHICLE— 510(k) K011227

Substantially Equivalent

Bruno Independent Living Aids, Inc.

FDA 510(k) clearance K011227 for REGAL MOTOTRIZED 3 WHEELED VEHICLE, Substantially Equivalent on 2001-05-11. Applicant: Bruno Independent Living Aids, Inc..

Clearance details

Applicant: Bruno Independent Living Aids, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2001-04-23
Decision date: 2001-05-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Oconomowoc, WI, 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.