AQUA ARK, IMMERSION HYDROBATH— 510(k) K861218

Substantially Equivalent

Aqua Ark, Inc.

FDA 510(k) clearance K861218 for AQUA ARK, IMMERSION HYDROBATH, Substantially Equivalent on 1986-04-18. Applicant: Aqua Ark, Inc..

Clearance details

Applicant: Aqua Ark, Inc.
Product code: Code ILJ
Advisory panel: Physical Medicine
Date received: 1986-03-31
Decision date: 1986-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, 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.