TEMPRA HEAT PACK— 510(k) K951383

Name: FDA 510(k) clearance K951383
Creator: U.S. Food and Drug Administration
Published: 1995-06-01

Substantially Equivalent for Some Indications

Tempra Technology, Inc.

FDA 510(k) clearance K951383 for TEMPRA HEAT PACK, Substantially Equivalent for Some Indications on 1995-06-01. Applicant: Tempra Technology, Inc.. Device class: 1.

Clearance details

Applicant: Tempra Technology, Inc.
Product code: Code IMD
Device class: Class 1
Regulation: 21 CFR 890.5710
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

Download summary PDF View on FDA.gov ↗

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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.