HYDROTONE I— 510(k) K890308

Substantially Equivalent

Hydrotonics Therapy Corp.

FDA 510(k) clearance K890308 for HYDROTONE I, Substantially Equivalent on 1989-01-31. Applicant: Hydrotonics Therapy Corp..

Clearance details

Applicant: Hydrotonics Therapy Corp.
Product code: Code ILJ
Advisory panel: Physical Medicine
Date received: 1989-01-23
Decision date: 1989-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.