K-number	K181149
Device name	Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
Applicant	Zenith Technical Innovations
Product code	IRP
Device class	Class II
Decision date	Aug 3, 2018
Decision	Substantially Equivalent
Regulation	890.5650

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Source

View the full FDA submission: accessdata.fda.gov

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Therm-X Pro, Therm-X AT, Therm-X Pro Athlete

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