BEWELL, MODEL SC 20— 510(k) K043326

Substantially Equivalent

Cycling and Health Tech. Industry R&D Center

FDA 510(k) clearance K043326 for BEWELL, MODEL SC 20, Substantially Equivalent on 2005-01-26. Applicant: Cycling and Health Tech. Industry R&D Center.

Clearance details

Applicant: Cycling and Health Tech. Industry R&D Center
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2004-12-02
Decision date: 2005-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

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.