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

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 Pro, Therm-x At, Therm-x Pro Athlete.

Pre-market Notification Details

Device IDK181149
510k NumberK181149
Device Name:Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-01
Decision Date2018-08-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850001096089 K181149 000
00850001096003 K181149 000
00850001096010 K181149 000
00850001096027 K181149 000
00850001096034 K181149 000
00850001096041 K181149 000
00850001096058 K181149 000
00850001096065 K181149 000
00850001096072 K181149 000
00850001096294 K181149 000

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