SUNPEX TECHNOLOGIES MODEL SE03— 510(k) K033019

Substantially Equivalent

Sunpex Technology Co., Ltd.

FDA 510(k) clearance K033019 for SUNPEX TECHNOLOGIES MODEL SE03, Substantially Equivalent on 2004-01-22. Applicant: Sunpex Technology Co., Ltd..

Clearance details

Applicant: Sunpex Technology Co., Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2003-09-26
Decision date: 2004-01-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Baltimore, MD, US

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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.