THERA-FIT— 510(k) K930821

Substantially Equivalent

Aquatherapy Systems, Inc.

FDA 510(k) clearance K930821 for THERA-FIT, Substantially Equivalent on 1994-11-09. Applicant: Aquatherapy Systems, Inc..

Clearance details

Applicant: Aquatherapy Systems, Inc.
Product code: Code ILJ
Advisory panel: Physical Medicine
Date received: 1993-02-17
Decision date: 1994-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette Hill, PA, US

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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.