LI'S ITCH STOPPER— 510(k) K963824

Name: FDA 510(k) clearance K963824
Creator: U.S. Food and Drug Administration
Published: 1996-12-12

Substantially Equivalent

Hontech Foundation For Medical Technology

FDA 510(k) clearance K963824 for LI'S ITCH STOPPER, Substantially Equivalent on 1996-12-12. Applicant: Hontech Foundation For Medical Technology. Device class: 2.

Clearance details

Applicant: Hontech Foundation For Medical Technology
Product code: Code IRT
Device class: Class 2
Regulation: 21 CFR 890.5740
Advisory panel: Physical Medicine
Date received: 1996-09-23
Decision date: 1996-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IRT

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Adverse events under product code IRT

product code IRT

Injury: 668
Total: 668

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.