Infrared Therapy System— 510(k) K142340

Substantially Equivalent

Beijing Huatai Healthcare Technology Co., Ltd.

FDA 510(k) clearance K142340 for Infrared Therapy System, Substantially Equivalent on 2014-12-02. Applicant: Beijing Huatai Healthcare Technology Co., Ltd..

Clearance details

Applicant: Beijing Huatai Healthcare Technology Co., Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2014-08-21
Decision date: 2014-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

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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.