eFOLDi Navigator Powerchair (STPC-A)— 510(k) K243110

Substantially Equivalent

Suntech UK , Ltd.

FDA 510(k) clearance K243110 for eFOLDi Navigator Powerchair (STPC-A), Substantially Equivalent on 2025-05-08. Applicant: Suntech UK , Ltd..

Clearance details

Applicant: Suntech UK , Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2024-09-30
Decision date: 2025-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehill, GB

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.