Thermotek Inc

FDA Filings

This page includes the latest FDA filings for Thermotek Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1648700
• FEI Number: 3000204260
• Name: THERMOTEK, INC.
• Owner & Operator: THERMOTEK, INC.
• Contact Address: 1200 Lakeside Parkway #200 --; Flowermound TX 75028 US
• Official Correspondent:
  • Sara - Lee
  • x-972-8744949-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1200 LAKESIDE PKWY STE 200 ; Flower Mound, TX 75028 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00850033615005 THERMOTEK, INC.	Evolution 2 0V12X1009M01	2023-08-30
GUDID 00850033615067 THERMOTEK, INC.	ARTEK PRO-01 0P9PTATP01UNVWRC01	2023-03-09
GUDID 00850033615050 THERMOTEK, INC.	ARTEK PRO-01 WRAP 0P9BATPUNVWRC01	2023-03-09
GUDID 00850033615036 THERMOTEK, INC.	ArTek Sport Wrap 0V9BSPRTUNVWRP01	2023-03-09
GUDID 00850033615012 THERMOTEK, INC.	ARTEK SPORT-01 w UNIV-01, Qty 1 0V9PTSPRT01UNV01	2023-03-09
PMN K191166 | PMC THERMOTEK, INC.	DigniCap Delta Scalp Cooling System	2019-08-23
GUDID B5850P9PTVT5000 THERMOTEK, INC.	VascuTherm5 0P9PTVT500	2019-03-12
GUDID B5850P9PTVT4000 THERMOTEK, INC.	VascuTherm4 0P9PTVt400	2019-03-12
GUDID B5850P9PT09SYS0 THERMOTEK, INC.	PT9 0P9PT09SYS	2019-03-12
PMN K103247 | JOW THERMOTEK, INC.	entre` System	2011-10-19
PMN K103247 | JOW THERMOTEK, INC.	VascuComp	2011-10-19
PMN K103247 THERMOTEK, INC.	VASCUCOMP	2010-12-10
PMN K061866 | JOW THERMOTEK, INC.	VascuTherm	2008-01-07
PMN K061866 | JOW THERMOTEK, INC.	ThermoComp	2008-01-07
PMN K061866 | JOW THERMOTEK, INC.	ProThermo	2008-01-07
PMN K061866 | JOW THERMOTEK, INC.	NanoTherm	2008-01-07
PMN K061866 | JOW THERMOTEK, INC.	ArTek Air	2008-01-07
PMN K061866 | ILO THERMOTEK, INC.	VascuTherm	2008-01-07
PMN K061866 | ILO THERMOTEK, INC.	ThermoComp	2008-01-07
PMN K061866 | ILO THERMOTEK, INC.	ProThermo	2008-01-07
PMN K061866 | ILO THERMOTEK, INC.	NanoTherm	2008-01-07
PMN K061866 | ILO THERMOTEK, INC.	ArTek Air	2008-01-07
PMN K061866 THERMOTEK, INC.	NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS	2006-08-22
PMN K945853 THERMOTEK, INC.	THERMOTEK H-300	1995-10-05
PMN K950711 THERMOTEK, INC.	T-350 THERAPEUTIC COOLING MACHINE	1995-07-06

Related Finance Registrations

NCAGE Code	1M9U8	THERMOTEK, INC.
CAGE Code	1M9U8	THERMOTEK, INC.
S.A.M. Registration	1M9U8 [847899911]	THERMOTEK, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082967735	Wuhu,China (Mainland) -> Long Beach, California	THERMAL THERAPY DEVICES COMPONENTS	14 CTN
2020072359504	Yantian,China (Mainland) -> Long Beach, California	THERMAL THERAPY DEVICES COMPONENTS	78 CTN
2020042840402	Yantian,China (Mainland) -> Long Beach, California	THERMAL THERAPY DEVICES COMPONENTS	227 CTN
2020042340888	Hong Kong,Hong Kong -> Long Beach, California	LITHIUM BATTERY	250 CTN
2020033145406	Yantian,China (Mainland) -> Long Beach, California	SOLENOID	20 PKG
2020010737665	Hong Kong,Hong Kong -> Long Beach, California	LITHIUM BATTERY	100 CTN
2020010353863	Hong Kong,Hong Kong -> Long Beach, California	LITHIUM BATTERY	100 CTN
2019122756286	Yantian,China (Mainland) -> Long Beach, California	THERMAL THERAPY DEVICES COMPONENTS	90 CTN