ers2 - ergoline Rehabilitation System— 510(k) K212883

Name: FDA 510(k) clearance K212883
Creator: U.S. Food and Drug Administration
Published: 2022-07-15

Substantially Equivalent

Ergoline GmbH

FDA 510(k) clearance K212883 for ers2 - ergoline Rehabilitation System, Substantially Equivalent on 2022-07-15. Applicant: Ergoline GmbH. Device class: 2.

Clearance details

Applicant: Ergoline GmbH
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
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 ↗

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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.