Data / Medical devices / United States / Thermotek, Inc.

Thermotek, Inc.: FDA-registered device maker in Flower Mound, TX, United States, 3 510(k) clearances

Name: Thermotek, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Thermotek, Inc. is registered with the FDA (registration 1648700) in Flower Mound, TX, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 4, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1648700
FEI number: 3000204260
Address: 1200 Lakeside Pkwy Ste 200, Flower Mound, TX, United States, 75028
Owner or operator: THERMOTEK, INC. (9016830)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: January 7, 2008
Registered through: 2026
Brand names listed: ArTek Pro, ArTek Sport, DigniCap Delta Scalp Cooling System, EchoRx, ProThermo, ThermoComp, VascuComp, VascuTherm and more

Devices it lists

Device	Product code	Class	Role	Source
Orthosis, Limb Brace	IQI	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Pack, Hot Or Cold, Water Circulating	ILO	2	Manufacturer, Specification developer	accessdata.fda.gov
Scalp Cooling System	PMC	2	Contract manufacturer	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Manufacturer, Specification developer	accessdata.fda.gov
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat	PFW	2	Repackager or relabeler	accessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	IMI	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 4, 2025	K240788	Ultrasound Stimulator	IMI	Substantially Equivalent	Jkh Health Co., Ltd.	accessdata.fda.gov
December 10, 2010	K103247	VASCUCOMP	JOW	Substantially Equivalent	Thermotek, Inc.	accessdata.fda.gov
August 22, 2006	K061866	NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS	JOW	Substantially Equivalent	Thermotek, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.