Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1648700

FEI Number

3000204260

Entity Name

THERMOTEK, INC.

City/State/Country

Flower Mound, TX, US

Establishment Address

1200 LAKESIDE PKWY STE 200, Flower Mound, TX 75028, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

THERMOTEK, INC. (Owner Number: 9016830)

Owner / Operator Contact Address

1200 Lakeside Parkway #200, --, Flowermound, TX 75028, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K061866

PMA Number

N/A

All Registered Proprietary Names

entre` System VascuComp VascuTherm ProThermo ArTek Pro ArTek Sport ThermoComp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2011-10-19
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2008-01-07
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2008-01-07

Official Correspondent

Sara Lee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

THERMOTEK, INC.

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
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

Similar Registrations

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3033981998	KOYA MEDICAL, INC.	Dallas, TX, US
3020703724	Therma Bright Inc.	Toronto Ontario, CA
3014491159	AIROS MEDICAL INC	Audubon, PA, US
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3009155917	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1648700. Last updated year: 2026. Please use registration number 1648700 when referencing this establishment in official correspondence.