ZENITH TECHNICAL INNOVATIONS, LLC

FDA Device Registration & Listing · Gurnee, IL, US · Registration 3014834638

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014834638
FEI Number
3014834638
Entity Name
ZENITH TECHNICAL INNOVATIONS, LLC
City/State/Country
Gurnee, IL, US
Establishment Address
1396 SAINT PAUL AVE, Gurnee, IL 60031, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Zenith Technical Innovations, LLC. (Owner Number: 10058299)
Owner / Operator Contact Address
1396 Saint Paul Ave, Gurnee, IL 60031, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181149
PMA Number
N/A

All Registered Proprietary Names

Therm-X Therm-X (Therm-X Home and Therm-X AT) Therm-X Therm-X Therm-X

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2021-06-14
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2021-06-14
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2021-06-14
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2024-06-28
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2024-06-28
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2024-06-28
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2021-06-14
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2021-06-14
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2021-06-14
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2023-09-22
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2023-09-22
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2023-09-22
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2018-08-17
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-08-17
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2018-08-17

Official Correspondent

Rebecca Schild

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zenith Technical Innovations, LLC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242140 Jiale Health Technology Shenzhen Co., Ltd. Air Compression Leg Massager (K-705) 2025-03-17
K170216 Tactile Systems Technology, Inc. (Dba Tactile Medical) Flexitouch System 2017-05-26
K100306 Covidien KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES 2010-05-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014834638. Last updated year: 2026. Please use registration number 3014834638 when referencing this establishment in official correspondence.
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