FDA.reportPublic FDA data

Circulating-fluid localized thermal therapy system pack, single-use

Definition
A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a single-use device.
GUDID devices
125
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00749756817103DeRoyalDEROYAL INDUSTRIES, INC.100C322016-09-12
00749756817110DeRoyalDEROYAL INDUSTRIES, INC.100C332016-09-12
00749756817257DeRoyalDEROYAL INDUSTRIES, INC.100C522016-09-12
00749756817264DeRoyalDEROYAL INDUSTRIES, INC.100C532016-09-12
00749756876292DeRoyalDEROYAL INDUSTRIES, INC.301C312016-09-12
00749756876315DeRoyalDEROYAL INDUSTRIES, INC.301C332016-09-12
00749756876339DeRoyalDEROYAL INDUSTRIES, INC.302C312016-09-12
00749756876353DeRoyalDEROYAL INDUSTRIES, INC.302C332016-09-12
00749756876377DeRoyalDEROYAL INDUSTRIES, INC.301C352016-09-12
00749756876407DeRoyalDEROYAL INDUSTRIES, INC.302C352016-09-12
00749756876421DeRoyalDEROYAL INDUSTRIES, INC.302C372016-09-12
00749756876582DeRoyalDEROYAL INDUSTRIES, INC.301C372016-09-12
00818566016102PremierProPRESTIGE AMERITECH, LTD.1238PP2020-09-04
00818566016119PremierProPRESTIGE AMERITECH, LTD.1239PP2020-09-04
00860008048318AqueCoolAdvanced Ambulatory, Inc.1.02024-07-19
00860008048325AqueCoolAdvanced Ambulatory, Inc.1.02024-07-19
00860008048332AqueCoolAdvanced Ambulatory, Inc.1.02024-07-19
10615089100304Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0032016-09-23
10615089100403Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0042016-09-23
10615089100809Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0082016-09-23
10615089101004Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0102016-09-23
10615089101202Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0122016-09-23
10615089101400Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0142016-09-23
10615089101707Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0172016-09-23
10615089101806Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0182016-09-23
10615089101905Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0192016-09-23
10615089102001Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0202016-09-23
10615089102100Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0212016-09-23
10615089102407Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0242016-09-23
10615089102605Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0262016-09-23
10615089103008Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0302016-09-23
10615089104104Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0412016-09-23
10615089104302Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0432016-09-23
10615089104401Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0442016-09-23
10615089105002Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-0502016-09-23
10615089111706Soft-TempADROIT MEDICAL SYSTEMS, INC.WD-0172016-09-23
10615089112000Soft-TempADROIT MEDICAL SYSTEMS, INC.WD-0202016-09-23
10615089113007Soft-TempADROIT MEDICAL SYSTEMS, INC.WD-0302016-09-23
10615089116008Soft-TempADROIT MEDICAL SYSTEMS, INC.WD-0602016-09-23
10615089121200Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-2122016-09-23
10615089121705Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-2172016-09-23
10615089122009Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-2202016-09-23
10615089122405Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-2242016-09-23
10615089123006Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-2302016-09-23
10615089126007Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-2602016-09-23
00850033615616ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UFTHERMOTEK, INC.0P9BCFKNMR3EXT-U 2026-02-23
00850033615647THERAPY SYSTEM, ARTEK PRO-02THERMOTEK, INC.0P9PTATP022026-02-23
00850033615081ThermoTek WRAP, BACK W/BRACE,LSO,ONE-SIZETHERMOTEK, INC.0P9BLSBXBK2026-02-21
00850033615104"ThermoTek WRAP, KNEE,ROM BRACE, 2XL, 13"""THERMOTEK, INC.0P9BRMLX13-2XL2026-02-21
00850033615135"ThermoTek WRAP, KNEE, ROM BRACE, 3XL, 13"""THERMOTEK, INC.0P9BRMLX13-3XL2026-02-21
00850033615142"ThermoTek WRAP, KNEE, ROM BRACE, L, 13"""THERMOTEK, INC.0P9BRMLX13-L2026-02-21
00850033615159ThermoTek WRAP, FOOT/ANKLE, SPU , UFTHERMOTEK, INC.0P9BFTAKMR3-U2026-02-21
00850033615166ThermoTek WRAP, HIP, MED, W/HARNESS, SPU, UFTHERMOTEK, INC.0P9BHPLBMR3-U2026-02-21
00850033615173ThermoTek WRAP, HIP, STND, SPU, UNFILLEDTHERMOTEK, INC.0P9BHPSBMR3-U2026-02-21
00850033615180"ThermoTek WRAP, KNEE, ROM BRACE, M, 13"""THERMOTEK, INC.0P9BRMSM13-M2026-02-21
00850033615197"ThermoTek WRAP, KNEE, ROM BRACE, XL, 13"""THERMOTEK, INC.0P9BRMLX13-XL2026-02-21
00850033615203ThermoTek WRAP, ARM, SPU, UNFILLEDTHERMOTEK, INC.0P9BLARMMR3-U2026-02-21
00850033615210ThermoTek WRAP, LOWER CERVICAL, SPU, UFTHERMOTEK, INC.0P9BLCRVMR3-U2026-02-21
00850033615234ThermoTek WRAP, KNEE, MED, SPU, UNFILLEDTHERMOTEK, INC.0P9BLFKNMR3-U2026-02-21
00850033615241ThermoTek WRAP, MINI, SPU, UNFILLEDTHERMOTEK, INC.0P9BMNWAMR3-U2026-02-21
00850033615265ThermoTek WRAP, DLX SHOULDER HALF ARM,SPU,UFTHERMOTEK, INC.0P9BMSWHMR3-U2026-02-21
00850033615296ThermoTek WRAP, KNEE,STD, HL, SPU, UFTHERMOTEK, INC.0P9BSFKNMR3-U2026-02-21
00850033615302ThermoTek WRAP, KNEE,WO/COMPRESION, SPU, UFTHERMOTEK, INC.0P9BSFNCMR3-U2026-02-21
00850033615319ThermoTek WRAP, SHOULDER, STANDARD, SPU, UFTHERMOTEK, INC.0P9BSSHLMR3-U2026-02-21
00850033615326ThermoTek WRAP, SHLD HALF ARM W/HRN, SPU, UFTHERMOTEK, INC.0P9BSSWHMR3-U2026-02-21
00850033615333ThermoTek WRAP, TOTAL CERVICAL, SPU, UFTHERMOTEK, INC.0P9BTCRVMR3-U2026-02-21
00850033615357ThermoTek WRAP, UPPER CERVICAL, SPU, UFTHERMOTEK, INC.0P9BUCRVMR3-U2026-02-21
00850033615364ThermoTek WRAP, UNIVERSAL U, SPU, UFTHERMOTEK, INC.0P9BUKNEMR3-U2026-02-21
00850033615395ThermoTek WRAP, WRIST/HAND, SPU, UFTHERMOTEK, INC.0P9BWTHDMR3-U2026-02-21
00850033615449ThermoTek WRAP,KNEE-HL,DLX,SG,GD,SPU,UF QTY 10 CTNTHERMOTEK, INC.0P9BDLXKNMR3-U-CTN2026-02-21
00850033615456ThermoTek WRAP, HIP, STND, SPU, UF, QTY 10 CTNTHERMOTEK, INC.0P9BHPSBMR3-U-CTN2026-02-21
00850033615463ThermoTek WRAP, KNEE, MED, SPU, UF,QTY 10 CTNTHERMOTEK, INC.0P9BLFKNMR3-U-CTN2026-02-21
00850033615470ThermoTek WRAP,DLX SHLDR,1/2 ARM,SPU,UF,QTY 10 CTNTHERMOTEK, INC.0P9BMSWHMR3-U-CTN2026-02-21
00850033615524ThermoTek WRAP, KNE,STD,HL,SPU,UF, QTY 10 CTNTHERMOTEK, INC.0P9BSFKNMR3-U-CTN2026-02-21
00850033615548ThermoTek WRAP,SHD 1/2 ARM,W/HRN,SPU,UF,QTY 10 CTNTHERMOTEK, INC.0P9BSSWHMR3-U-CTN2026-02-21
00850033615579ThermoTek WRAP,WRIST/HAND,SPU,UF,QTY 10 CTNTHERMOTEK, INC.0P9BWTHDMR3-U-CTN2026-02-21
00850033615074ThermoTek Inc Foot/Ankle Wrap, Single, SPUTHERMOTEK, INC.0P9BANKLMR3-U2026-02-18
00850033615098ThermoTek WRAP, BACK, SPU, UNFILLEDTHERMOTEK, INC.0P9BBACKMR3-U2026-02-18
00850033615111ThermoTek Knee/Full Leg Segmented, Circumferential SPU WrapTHERMOTEK, INC.0P9BCFKNMR3-U2026-02-18
00850033615128ThermoTek WRAP, KNEE-HL, DLX, SG,GD,SPU, UFTHERMOTEK, INC.0P9BDLXKNMR3-U2026-02-18