SUNTEC Mechanical Wheelchair, model ST-WL-1000— 510(k) K152878

Substantially Equivalent

Danyang Suntec Auto Parts Co., Ltd.

FDA 510(k) clearance K152878 for SUNTEC Mechanical Wheelchair, model ST-WL-1000, Substantially Equivalent on 2016-02-03. Applicant: Danyang Suntec Auto Parts Co., Ltd..

Clearance details

Applicant: Danyang Suntec Auto Parts Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2015-09-30
Decision date: 2016-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhenjiang, CN

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.