Winner Transfer Wheelchair— 510(k) K162328

Substantially Equivalent

Winner SG Pte, Ltd.

FDA 510(k) clearance K162328 for Winner Transfer Wheelchair, Substantially Equivalent on 2017-05-11. Applicant: Winner SG Pte, Ltd..

Clearance details

Applicant: Winner SG Pte, Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2016-08-19
Decision date: 2017-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

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.