510(k) K160849— WS(TM) Far-Infrared Therapy Unit, Model KP-B210

Substantially Equivalent

Ws Far IR Medical Technology Co., Ltd.

Clearance details

Applicant: Ws Far IR Medical Technology Co., Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2016-03-28
Decision date: 2016-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

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.