PT-PAC PORTABLE HEATING PAD— 510(k) K963887

Name: FDA 510(k) clearance K963887
Creator: U.S. Food and Drug Administration
Published: 1997-03-31

Substantially Equivalent

Anthony A. Chiurco

FDA 510(k) clearance K963887 for PT-PAC PORTABLE HEATING PAD, Substantially Equivalent on 1997-03-31. Applicant: Anthony A. Chiurco. Device class: 2.

Clearance details

Applicant: Anthony A. Chiurco
Product code: Code IRT
Device class: Class 2
Regulation: 21 CFR 890.5740
Advisory panel: Physical Medicine
Date received: 1996-09-26
Decision date: 1997-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Levitown Road, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IRT

view all

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.