Name: Predicase
Price: 199 USD

K-number	K080465
Device name	WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES
Applicant	Ws Far IR Medical Technology Co., Ltd.
Product code	ILY
Device class	Class II
Decision date	Jul 18, 2008
Decision	Substantially Equivalent
Regulation	890.5500

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES

Everything you need for a 510(k) submission. Nothing you don't.