AMISH COUNTRY SPA— 510(k) K911758

Substantially Equivalent

Fox Pool Corp.

FDA 510(k) clearance K911758 for AMISH COUNTRY SPA, Substantially Equivalent on 1991-10-02. Applicant: Fox Pool Corp..

Clearance details

Applicant: Fox Pool Corp.
Product code: Code ILJ
Advisory panel: Physical Medicine
Date received: 1991-04-18
Decision date: 1991-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

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.