Massager, Powered Inflatable Tube

Zenith Technical Innovations

The following data is part of a premarket notification filed by Zenith Technical Innovations with the FDA for Therm-x.

Pre-market Notification Details

Device IDK193550
510k NumberK193550
Device Name:Therm-X
ClassificationMassager, Powered Inflatable Tube
Applicant Zenith Technical Innovations 1396 St. Paul Ave. Gurnee,  IL  60031
ContactGreg Binversie
CorrespondentRita King
MethodSense, Inc. 1 Copley Parkway Suite 410 Morrisville,  NC  27560
Product CodeIRP  
Subsequent Product CodeILO
Subsequent Product CodeJOW
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyPhysical Medicine
510k Review PanelPhysical Medicine
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-02-28

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