eFOLDi Scooter, Lite— 510(k) K223492

Substantially Equivalent

Suntech UK , Ltd.

FDA 510(k) clearance K223492 for eFOLDi Scooter, Lite, Substantially Equivalent on 2023-02-22. Applicant: Suntech UK , Ltd..

Clearance details

Applicant: Suntech UK , Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2022-11-21
Decision date: 2023-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehill, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

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.