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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name massager, powered inflatable tube
510(k) Number K181149
Device Name Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
Applicant
Zenith Technical Innovations
1396 St. Paul Ave
Gurnee,  IL  60031
Applicant Contact Greg Binversie
Correspondent
MethodSense, Inc.
1 Copley Parkway, Suite 410
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Codes
ILO   JOW  
Date Received05/01/2018
Decision Date 08/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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