Athena 190— 510(k) K173360

Substantially Equivalent

Medical Rehab Products, LLC

FDA 510(k) clearance K173360 for Athena 190, Substantially Equivalent on 2018-05-17. Applicant: Medical Rehab Products, LLC.

Clearance details

Applicant: Medical Rehab Products, LLC
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2017-10-26
Decision date: 2018-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreat, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.