HOMECARE CLINICS INFRAHEAT #230— 510(k) K854151

Substantially Equivalent

Nelkin/Piper Intl.

FDA 510(k) clearance K854151 for HOMECARE CLINICS INFRAHEAT #230, Substantially Equivalent on 1986-01-30. Applicant: Nelkin/Piper Intl..

Clearance details

Applicant: Nelkin/Piper Intl.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 1985-10-11
Decision date: 1986-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.