510(k) K962038— PES HOT/COLD COMPRESS

Substantially Equivalent

Princeton Electronic Systems, Inc.

Clearance details

Applicant: Princeton Electronic Systems, Inc.
Product code: Code IRT
Advisory panel: Physical Medicine
Date received: 1996-05-24
Decision date: 1996-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton Jct, NJ, US

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.