SupaChair Powered Wheelchair— 510(k) K173315

Substantially Equivalent

Eurogreen International, Inc.

FDA 510(k) clearance K173315 for SupaChair Powered Wheelchair, Substantially Equivalent on 2018-02-13. Applicant: Eurogreen International, Inc..

Clearance details

Applicant: Eurogreen International, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2017-10-19
Decision date: 2018-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chang-Hua County, CN

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.