SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018— 510(k) K020462

Substantially Equivalent

Rolor Electronics Corp.

FDA 510(k) clearance K020462 for SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018, Substantially Equivalent on 2002-09-16. Applicant: Rolor Electronics Corp..

Clearance details

Applicant: Rolor Electronics Corp.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2002-02-12
Decision date: 2002-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

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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.