SHOWER STOOL W/HANDLES— 510(k) K823154

Substantially Equivalent

Orthion Corp.

FDA 510(k) clearance K823154 for SHOWER STOOL W/HANDLES, Substantially Equivalent on 1982-11-05. Applicant: Orthion Corp..

Clearance details

Applicant: Orthion Corp.
Product code: Code IKX
Advisory panel: Physical Medicine
Date received: 1982-10-20
Decision date: 1982-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code IKX

product code IKX

Death: 11
Total: 11

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.