BERKELEY CHAIR— 510(k) K823085

Substantially Equivalent

Berkeley Electric Wheelchair Co.

FDA 510(k) clearance K823085 for BERKELEY CHAIR, Substantially Equivalent on 1983-01-21. Applicant: Berkeley Electric Wheelchair Co..

Clearance details

Applicant: Berkeley Electric Wheelchair Co.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1982-10-19
Decision date: 1983-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.