PORT-O-HEAT, MODEL 0100— 510(k) K882151

Name: FDA 510(k) clearance K882151
Creator: U.S. Food and Drug Administration
Published: 1988-11-04

Substantially Equivalent

Arthotronics, Inc.

FDA 510(k) clearance K882151 for PORT-O-HEAT, MODEL 0100, Substantially Equivalent on 1988-11-04. Applicant: Arthotronics, Inc.. Device class: 2.

Clearance details

Applicant: Arthotronics, Inc.
Product code: Code IRT
Device class: Class 2
Regulation: 21 CFR 890.5740
Advisory panel: Physical Medicine
Date received: 1988-05-23
Decision date: 1988-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, 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.