VASCUCOMP
THERMOTEK, INC.
THERMOTEK, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1648700 | 3000204260 | THERMOTEK, INC. | 1 | Y | 2026-01-01 | 1200 LAKESIDE PKWY STE 200 Flower Mound TX US 75028 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 81326 | 1707239164 | K240788 | Ultrasound Stimulator | IMI | 2025-06-04 |
| 81326 | 1836463954 | K160318 | PlasmaFlow | JOW | 2016-04-01 |
| 81326 | 2061852927 | K103247 | VASCUCOMP | JOW | 2010-12-10 |
| 81326 | 1800312558 | K061866 | NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS | JOW | 2006-08-22 |
| 81326 | 1925264377 |
Product Codes Associated With Registrations#
PMN#
NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS
THERMOTEK, INC.
THERMOTEK H-300
THERMOTEK, INC.
T-350 THERAPEUTIC COOLING MACHINE
THERMOTEK, INC.
GUDID#
Echo Ultrasound Device (PRC) - Echo Ultrasound Device, Carton
2026-02-23
Echo Ultrasound Device (PRC) - Echo Ultrasound Device, Single
2026-02-23
Echo Ultrasound Device (USA) - Echo Ultrasound Device (USA), Carton
2026-02-23
Echo Ultrasound Device (USA) - Echo Ultrasound Device (USA), Single
2026-02-23
Echo BOX, DRESSING & GEL POD PACK, USND, PRC - Echo BOX, DRESSING & GEL POD PACK, USND, PRC Single
2026-02-23
Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXES - 0V52XX1003JK01-CTN
2026-02-23
Echo Ultra Sound Gel Pods, Carton - 0V52XX1004JK01-CTN
2026-02-23
Echo Ultra Sound Gel Pod, Single - 0V52XX1004JK01
2026-02-23
Echo APPLICATOR, SINGLE, USND - 0V52XX1005JK01
2026-02-23
Echo POWER SUPPLY, CORD, SINGLE, USND - 0V52XX1006JK01
2026-02-23
Echo BELT CLIP, DEVICE PRTCTR, SNGL,USND - 0V52XX1007JK01
2026-02-23
Echo ARM STRAP, DEVICE PRTCTR, SNG, USND - 0V52XX1008JK01
2026-02-23
Echo GEL, TUBE, SINGLE, USND - 0V52XX1009JK01
2026-02-23
echoRx, MANUAL, USER, SINGLE, USND - 0V52XX1010JK01
2026-02-23
echoRx, GUIDE,QUICK START,SNGL,USND - 0V52XX1011JK01
2026-02-23
ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UF - 0P9BCFKNMR3EXT-U
2026-02-23
Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXES - 0V52XX1012JK01-CTN
2026-02-23
Echo BOX, DRESSING & GEL POD PACK, USND, USA - 0V52XX1012JK01
2026-02-23
THERAPY SYSTEM, ARTEK PRO-02 - 0P9PTATP02
2026-02-23
ThermoTek WRAP, BACK W/BRACE,LSO,ONE-SIZE - WRAP, BACK W/BRACE,LSO,ONE-SIZE
2026-02-21
"ThermoTek WRAP, KNEE,ROM BRACE, 2XL, 13""" - "WRAP, KNEE,ROM BRACE, 2XL, 13"""
2026-02-21
"ThermoTek WRAP, KNEE, ROM BRACE, 3XL, 13""" - "WRAP, KNEE, ROM BRACE, 3XL, 13"""
2026-02-21
"ThermoTek WRAP, KNEE, ROM BRACE, L, 13""" - "WRAP, KNEE, ROM BRACE, L, 13"""
2026-02-21
ThermoTek WRAP, FOOT/ANKLE, SPU , UF - WRAP, FOOT/ANKLE, SPU , UF
2026-02-21
ThermoTek WRAP, HIP, MED, W/HARNESS, SPU, UF - WRAP, HIP, MED, W/HARNESS, SPU, UF
2026-02-21
ThermoTek WRAP, HIP, STND, SPU, UNFILLED - WRAP, HIP, STND, SPU, UNFILLED
2026-02-21
"ThermoTek WRAP, KNEE, ROM BRACE, M, 13""" - "WRAP, KNEE, ROM BRACE, M, 13"""
2026-02-21
"ThermoTek WRAP, KNEE, ROM BRACE, XL, 13""" - "WRAP, KNEE, ROM BRACE, XL, 13"""
2026-02-21
ThermoTek WRAP, ARM, SPU, UNFILLED - WRAP, ARM, SPU, UNFILLED
2026-02-21
ThermoTek WRAP, LOWER CERVICAL, SPU, UF - WRAP, LOWER CERVICAL, SPU, UF
2026-02-21
ThermoTek WRAP, KNEE, MED, SPU, UNFILLED - WRAP, KNEE, MED, SPU, UNFILLED
2026-02-21
ThermoTek WRAP, MINI, SPU, UNFILLED - WRAP, MINI, SPU, UNFILLED
2026-02-21
ThermoTek WRAP, DLX SHOULDER HALF ARM,SPU,UF - WRAP, DLX SHOULDER HALF ARM,SPU,UF
2026-02-21
ThermoTek WRAP, DVT, CALF SET, PUSH, SPU - WRAP, DVT, CALF SET, PUSH, SPU
2026-02-21
ThermoTek WRAP, KNEE,STD, HL, SPU, UF - WRAP, KNEE,STD, HL, SPU, UF
2026-02-21
ThermoTek WRAP, KNEE,WO/COMPRESION, SPU, UF - WRAP, KNEE,WO/COMPRESION, SPU, UF
2026-02-21
ThermoTek WRAP, SHOULDER, STANDARD, SPU, UF - WRAP, SHOULDER, STANDARD, SPU, UF
2026-02-21
ThermoTek WRAP, SHLD HALF ARM W/HRN, SPU, UF - WRAP, SHLD HALF ARM W/HRN, SPU, UF
2026-02-21
ThermoTek WRAP, TOTAL CERVICAL, SPU, UF - WRAP, TOTAL CERVICAL, SPU, UF
2026-02-21
ThermoTek WRAP, UPPER CERVICAL, SPU, UF - WRAP, UPPER CERVICAL, SPU, UF
2026-02-21