LANDLEX, MODEL: 402X— 510(k) K083303

Name: FDA 510(k) clearance K083303
Creator: U.S. Food and Drug Administration
Published: 2009-01-26

Substantially Equivalent

Besteam Technology, Inc.

FDA 510(k) clearance K083303 for LANDLEX, MODEL: 402X, Substantially Equivalent on 2009-01-26. Applicant: Besteam Technology, Inc.. Device class: 2.

Clearance details

Applicant: Besteam Technology, Inc.
Product code: Code INI
Device class: Class 2
Regulation: 21 CFR 890.3800
Advisory panel: Physical Medicine
Date received: 2008-11-10
Decision date: 2009-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Banqiao, TW

Download summary PDF View on FDA.gov ↗

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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.