e-fix E35/E36— 510(k) K161241

Substantially Equivalent

Alber GmbH

FDA 510(k) clearance K161241 for e-fix E35/E36, Substantially Equivalent on 2016-10-05. Applicant: Alber GmbH.

Clearance details

Applicant: Alber GmbH
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2016-05-02
Decision date: 2016-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albstadt, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.