SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21— 510(k) K041883

Substantially Equivalent

Leonhard Lang GmbH

FDA 510(k) clearance K041883 for SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21, Substantially Equivalent on 2004-09-07. Applicant: Leonhard Lang GmbH.

Clearance details

Applicant: Leonhard Lang GmbH
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2004-07-12
Decision date: 2004-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.