FDA.reportPublic FDA data

ZENITH TECHNICAL INNOVATIONS, LLC

Matched from indexed company URL: Zenith Technical Innovations

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30148346383014834638ZENITH TECHNICAL INNOVATIONS, LLC1N2026-01-011396 SAINT PAUL AVE Gurnee IL US 60031

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2213781390723447K240125Therm-X (Home); Therm-X (AT)JOW2024-06-21
2213781852766824K231912Therm-XIRP2023-07-27
2213781805691090K193550Therm-XIRP2020-02-28
2213782058964515K190854Therm-XIRP2019-05-10
2213781508147597K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteIRP2018-08-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IRP42023-07-27
JOW12024-06-21

PMN#

Therm-X

2023-07-27

Zenith Technical Innovations

Therm-X

2020-02-28

Zenith Technical Innovations

Therm-X

2019-05-10

Zenith Technical Innovations

GUDID#

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