INFRARED HEATING DEVICE— 510(k) K140865

Substantially Equivalent

Pro Medical Supplies, Inc.

FDA 510(k) clearance K140865 for INFRARED HEATING DEVICE, Substantially Equivalent on 2014-09-03. Applicant: Pro Medical Supplies, Inc..

Clearance details

Applicant: Pro Medical Supplies, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2014-04-03
Decision date: 2014-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.