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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 K190854
Device Name Therm-X
Applicant
Zenith Technical Innovations
1396 St. Paul Ave.
Gurnee,  IL  60031
Applicant Contact Greg Binversie
Correspondent
MethodSense, Inc.
1 Copley Pkwy.,
Suite 410
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Codes
ILO   JOW  
Date Received04/02/2019
Decision Date 05/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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