LOWER EXTREMITY SUPPORT SYSTEM-LESS— 510(k) K810433

Substantially Equivalent

Walgen Medical Innoventions

FDA 510(k) clearance K810433 for LOWER EXTREMITY SUPPORT SYSTEM-LESS, Substantially Equivalent on 1981-03-13. Applicant: Walgen Medical Innoventions.

Clearance details

Applicant: Walgen Medical Innoventions
Product code: Code FWZ
Advisory panel: General, Plastic Surgery
Date received: 1981-02-19
Decision date: 1981-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.