LODE MODEL CORIVAL ERGOMETER— 510(k) K851097

Substantially Equivalent

Lode Corp.

FDA 510(k) clearance K851097 for LODE MODEL CORIVAL ERGOMETER, Substantially Equivalent on 1985-06-18. Applicant: Lode Corp..

Clearance details

Applicant: Lode Corp.
Product code: Code ISD
Advisory panel: Physical Medicine
Date received: 1985-03-19
Decision date: 1985-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

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.