KOOYCHAIR (PEDIATRIC)— 510(k) K862886

Substantially Equivalent

Mednet, Inc.

FDA 510(k) clearance K862886 for KOOYCHAIR (PEDIATRIC), Substantially Equivalent on 1986-08-13. Applicant: Mednet, Inc..

Clearance details

Applicant: Mednet, Inc.
Product code: Code INM
Advisory panel: Physical Medicine
Date received: 1986-07-22
Decision date: 1986-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Battle Creek, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code INM

product code INM

Death: 3
Total: 3

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.