WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES— 510(k) K080465
Substantially EquivalentWs Far IR Medical Technology Co., Ltd.
FDA 510(k) clearance K080465 for WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES, Substantially Equivalent on 2008-07-18. Applicant: 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flagstaff, AZ, US
Adverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.