MEDI-PACK— 510(k) K895860

Substantially Equivalent

Heatmax Mfg., Inc.

FDA 510(k) clearance K895860 for MEDI-PACK, Substantially Equivalent on 1990-01-02. Applicant: Heatmax Mfg., Inc..

Clearance details

Applicant: Heatmax Mfg., Inc.
Product code: Code IMD
Advisory panel: Physical Medicine
Date received: 1989-10-03
Decision date: 1990-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.