HOT OR COLD PACK (THERMIPAQ)— 510(k) K921446

Substantially Equivalent

Thermionics Corp.

FDA 510(k) clearance K921446 for HOT OR COLD PACK (THERMIPAQ), Substantially Equivalent on 1992-07-13. Applicant: Thermionics Corp..

Clearance details

Applicant: Thermionics Corp.
Product code: Code IME
Advisory panel: Physical Medicine
Date received: 1992-03-27
Decision date: 1992-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, IL, US

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Adverse events under product code IME

product code IME

Other: 1
Total: 1

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.