HYDROTONE I— 510(k) K890308

Name: FDA 510(k) clearance K890308
Creator: U.S. Food and Drug Administration
Published: 1989-01-31

Substantially Equivalent

Hydrotonics Therapy Corp.

FDA 510(k) clearance K890308 for HYDROTONE I, Substantially Equivalent on 1989-01-31. Applicant: Hydrotonics Therapy Corp.. Device class: 2.

Clearance details

Applicant: Hydrotonics Therapy Corp.
Product code: Code ILJ
Device class: Class 2
Regulation: 21 CFR 890.5100
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 ↗

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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.