WALK400H— 510(k) K091054

Name: FDA 510(k) clearance K091054
Creator: U.S. Food and Drug Administration
Published: 2009-07-27

Substantially Equivalent

Et Medical Devices Spa

FDA 510(k) clearance K091054 for WALK400H, Substantially Equivalent on 2009-07-27. Applicant: Et Medical Devices Spa. Device class: 2.

Clearance details

Applicant: Et Medical Devices Spa
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2009-04-13
Decision date: 2009-07-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Cavareno(Tn), IT

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.