510(k) K803299— COLD/HOT PACK

Substantially Equivalent

W.G. Whitney Corp.

Clearance details

Applicant: W.G. Whitney Corp.
Product code: Code IME
Advisory panel: Physical Medicine
Date received: 1980-12-30
Decision date: 1981-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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.