e-motion M25— 510(k) K221215

Substantially Equivalent

Alber GmbH

FDA 510(k) clearance K221215 for e-motion M25, Substantially Equivalent on 2022-05-24. Applicant: Alber GmbH.

Clearance details

Applicant: Alber GmbH
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2022-04-27
Decision date: 2022-05-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Albstadt-Tailfingen, 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.