IKON 40 Manual Wheelchair— 510(k) K190550

Substantially Equivalent

Broda Seating (Broda Lp)

FDA 510(k) clearance K190550 for IKON 40 Manual Wheelchair, Substantially Equivalent on 2019-07-01. Applicant: Broda Seating (Broda Lp).

Clearance details

Applicant: Broda Seating (Broda Lp)
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2019-03-05
Decision date: 2019-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kitchener, CA

Download summary PDF View on FDA.gov ↗

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.