K951383

Substantially Equivalent for Some Indications

TEMPRA HEAT PACK

Applicant: Tempra Technology, Inc.
Product code: IMD
Advisory panel: Physical Medicine
Date received: 1995-03-27
Decision date: 1995-06-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Sarasota, FL, US

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.