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 Number1648700
FEI Number3000204260
NameTHERMOTEK, INC.
Owner & OperatorTHERMOTEK, INC.
Contact Address1200 Lakeside Parkway #200 --
Flowermound TX 75028 US
Official Correspondent
  • Sara - Lee
  • x-972-8744949-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1200 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
DeviceDate
THERMOTEK, INC.
 THERAPY SYSTEM, ARTEK PRO-02 0P9PTATP022026-03-03
THERMOTEK, INC.
 Echo BOX, DRESSING & GEL POD PACK, USND, USA 0V52XX1012JK012026-03-03
THERMOTEK, INC.
 Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXES 0V52XX1012JK01-CTN 2026-03-03
THERMOTEK, INC.
 ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UF 0P9BCFKNMR3EXT-U 2026-03-03
THERMOTEK, INC.
 echoRx, GUIDE,QUICK START,SNGL,USND 0V52XX1011JK012026-03-03
THERMOTEK, INC.
 echoRx, MANUAL, USER, SINGLE, USND 0V52XX1010JK012026-03-03
THERMOTEK, INC.
 Echo GEL, TUBE, SINGLE, USND 0V52XX1009JK012026-03-03
THERMOTEK, INC.
 Echo ARM STRAP, DEVICE PRTCTR, SNG, USND 0V52XX1008JK012026-03-03
THERMOTEK, INC.
 Echo BELT CLIP, DEVICE PRTCTR, SNGL,USND 0V52XX1007JK012026-03-03
THERMOTEK, INC.
 Echo POWER SUPPLY, CORD, SINGLE, USND 0V52XX1006JK012026-03-03
THERMOTEK, INC.
 Echo APPLICATOR, SINGLE, USND 0V52XX1005JK012026-03-03
THERMOTEK, INC.
 Echo Ultra Sound Gel Pod, Single 0V52XX1004JK012026-03-03
THERMOTEK, INC.
 Echo Ultra Sound Gel Pods, Carton 0V52XX1004JK01-CTN2026-03-03
THERMOTEK, INC.
 Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXES 0V52XX1003JK01-CTN2026-03-03
THERMOTEK, INC.
 Echo BOX, DRESSING & GEL POD PACK, USND, PRC 0V52XX1003JK01 2026-03-03
THERMOTEK, INC.
 Echo Ultrasound Device (USA) 0V52XX1002JK012026-03-03
THERMOTEK, INC.
 Echo Ultrasound Device (USA) 0V52XX1002JK01-CTN2026-03-03
THERMOTEK, INC.
 Echo Ultrasound Device (PRC) 0V52XX1001JK012026-03-03
THERMOTEK, INC.
 Echo Ultrasound Device (PRC) 0V52XX1001JK01-CTN2026-03-03
THERMOTEK, INC.
 ThermoTek WRAP,WRIST/HAND,SPU,UF,QTY 10 CTN 0P9BWTHDMR3-U-CTN2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP,SHD 1/2 ARM,W/HRN,SPU,UF,QTY 10 CTN 0P9BSSWHMR3-U-CTN2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, KNE,STD,HL,SPU,UF, QTY 10 CTN 0P9BSFKNMR3-U-CTN2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTN 0P9BNDVTCA4-CTN2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP,DLX SHLDR,1/2 ARM,SPU,UF,QTY 10 CTN 0P9BMSWHMR3-U-CTN2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, KNEE, MED, SPU, UF,QTY 10 CTN 0P9BLFKNMR3-U-CTN2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, HIP, STND, SPU, UF, QTY 10 CTN 0P9BHPSBMR3-U-CTN2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP,KNEE-HL,DLX,SG,GD,SPU,UF QTY 10 CTN 0P9BDLXKNMR3-U-CTN2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, WRIST/HAND, SPU, UF 0P9BWTHDMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, UNIVERSAL U, SPU, UF 0P9BUKNEMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, UPPER CERVICAL, SPU, UF 0P9BUCRVMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, TOTAL CERVICAL, SPU, UF 0P9BTCRVMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, SHLD HALF ARM W/HRN, SPU, UF 0P9BSSWHMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, SHOULDER, STANDARD, SPU, UF 0P9BSSHLMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, KNEE,WO/COMPRESION, SPU, UF 0P9BSFNCMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, KNEE,STD, HL, SPU, UF 0P9BSFKNMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, DVT, CALF SET, PUSH, SPU 0P9BNDVTCA42026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, DLX SHOULDER HALF ARM,SPU,UF 0P9BMSWHMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, MINI, SPU, UNFILLED 0P9BMNWAMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, KNEE, MED, SPU, UNFILLED 0P9BLFKNMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, LOWER CERVICAL, SPU, UF 0P9BLCRVMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, ARM, SPU, UNFILLED 0P9BLARMMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, KNEE, ROM BRACE, XL, 13" 0P9BRMLX13-XL2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, KNEE, ROM BRACE, M, 13" 0P9BRMSM13-M2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, HIP, STND, SPU, UNFILLED 0P9BHPSBMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, HIP, MED, W/HARNESS, SPU, UF 0P9BHPLBMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, FOOT/ANKLE, SPU , UF 0P9BFTAKMR3-U2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, KNEE, ROM BRACE, L, 13" 0P9BRMLX13-L2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, KNEE, ROM BRACE, 3XL, 13" 0P9BRMLX13-3XL2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, KNEE,ROM BRACE, 2XL, 13" 0P9BRMLX13-2XL2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP, BACK W/BRACE,LSO,ONE-SIZE 0P9BLSBXBK2026-03-02
THERMOTEK, INC.
 ThermoTek WRAP,KN/FL,SG GRD,CRCMF,QTY 10 CTN 0P9BCFKNMR3-U-CTN2026-02-26
THERMOTEK, INC.
 ThermoTek WRAP, BACK, SPU, UF, QTY 10 CTN 0P9BBACKMR3-U-CTN2026-02-26
THERMOTEK, INC.
 ThermoTek Inc Foot/Ankle Wrap-Carton 0P9BANKLMR3-U-CTN2026-02-26
THERMOTEK, INC.
 ThermoTek WRAP, KNEE-HL, DLX, SG,GD,SPU, UF 0P9BDLXKNMR3-U2026-02-26
THERMOTEK, INC.
 ThermoTek Knee/Full Leg Segmented, Circumferential SPU Wrap 0P9BCFKNMR3-U2026-02-26
THERMOTEK, INC.
 ThermoTek WRAP, BACK, SPU, UNFILLED 0P9BBACKMR3-U2026-02-26
THERMOTEK, INC.
 ThermoTek Inc Foot/Ankle Wrap, Single, SPU 0P9BANKLMR3-U2026-02-26
THERMOTEK, INC.
 Evolution 2 0V12X1009M012023-08-30
THERMOTEK, INC.
 ARTEK PRO-01 0P9PTATP01UNVWRC012023-03-09
THERMOTEK, INC.
 ARTEK PRO-01 WRAP 0P9BATPUNVWRC012023-03-09
THERMOTEK, INC.
 ArTek Sport Wrap 0V9BSPRTUNVWRP012023-03-09
THERMOTEK, INC.
 ARTEK SPORT-01 w UNIV-01, Qty 1 0V9PTSPRT01UNV012023-03-09
THERMOTEK, INC.
DigniCap Delta Scalp Cooling System2019-08-23
THERMOTEK, INC.
 VascuTherm5 0P9PTVT5002019-03-12
THERMOTEK, INC.
 VascuTherm4 0P9PTVt4002019-03-12
THERMOTEK, INC.
 PT9 0P9PT09SYS2019-03-12
THERMOTEK, INC.
entre` System2011-10-19
THERMOTEK, INC.
VascuComp2011-10-19
THERMOTEK, INC.
VASCUCOMP2010-12-10
THERMOTEK, INC.
VascuTherm2008-01-07
THERMOTEK, INC.
ThermoComp2008-01-07
THERMOTEK, INC.
ProThermo2008-01-07
THERMOTEK, INC.
NanoTherm2008-01-07
THERMOTEK, INC.
ArTek Air2008-01-07
THERMOTEK, INC.
VascuTherm2008-01-07
THERMOTEK, INC.
ThermoComp2008-01-07
THERMOTEK, INC.
ProThermo2008-01-07
THERMOTEK, INC.
NanoTherm2008-01-07
THERMOTEK, INC.
ArTek Air2008-01-07
THERMOTEK, INC.
NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS2006-08-22
THERMOTEK, INC.
THERMOTEK H-3001995-10-05
THERMOTEK, INC.
T-350 THERAPEUTIC COOLING MACHINE1995-07-06

Related Finance Registrations
NCAGE Code1M9U8THERMOTEK, INC.
CAGE Code1M9U8THERMOTEK, INC.
S.A.M. Registration1M9U8 [847899911]THERMOTEK, INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020082967735Wuhu,China (Mainland) -> Long Beach, CaliforniaTHERMAL THERAPY DEVICES COMPONENTS14 CTN
2020072359504Yantian,China (Mainland) -> Long Beach, CaliforniaTHERMAL THERAPY DEVICES COMPONENTS78 CTN
2020042840402Yantian,China (Mainland) -> Long Beach, CaliforniaTHERMAL THERAPY DEVICES COMPONENTS227 CTN
2020042340888Hong Kong,Hong Kong -> Long Beach, CaliforniaLITHIUM BATTERY250 CTN
2020033145406Yantian,China (Mainland) -> Long Beach, CaliforniaSOLENOID20 PKG
2020010737665Hong Kong,Hong Kong -> Long Beach, CaliforniaLITHIUM BATTERY100 CTN
2020010353863Hong Kong,Hong Kong -> Long Beach, CaliforniaLITHIUM BATTERY100 CTN
2019122756286Yantian,China (Mainland) -> Long Beach, CaliforniaTHERMAL THERAPY DEVICES COMPONENTS90 CTN
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