ers2 - ergoline Rehabilitation System— 510(k) K212883

Substantially Equivalent

Ergoline GmbH

FDA 510(k) clearance K212883 for ers2 - ergoline Rehabilitation System, Substantially Equivalent on 2022-07-15. Applicant: Ergoline GmbH.

Clearance details

Applicant: Ergoline GmbH
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2021-09-10
Decision date: 2022-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bitz, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.