RESTORE, THERMACELLS (HOT PACK I)— 510(k) K953442

Substantially Equivalent for Some Indications

Neal Dunning Assoc., Inc.

FDA 510(k) clearance K953442 for RESTORE, THERMACELLS (HOT PACK I), Substantially Equivalent for Some Indications on 1995-10-31. Applicant: Neal Dunning Assoc., Inc..

Clearance details

Applicant: Neal Dunning Assoc., Inc.
Product code: Code IMD
Advisory panel: Physical Medicine
Date received: 1995-07-17
Decision date: 1995-10-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Bethesda, MD, US

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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.