FDA.reportPublic FDA data

Circulating-fluid localized thermal therapy system control unit

Definition
An electrically-powered device intended to be used as part of a localized circulating-fluid thermal therapy system to pump heated and/or cooled fluid (e.g., water) through an externally applied pack (not included) for localized hot and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It includes a fluid pump and either a heater, or a means for cold therapy (e.g., refrigeration unit, permitting addition of independently cooled ice water) or both; it does not include an air pump for wrap inflation. It is intended for use in both professional and home settings.
GUDID devices
75
Last updated
2026-09-29 04:02:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00749756401678DeRoyalDEROYAL INDUSTRIES, INC.13-809A-01-COSM2026-09-18
00860015782304KOOL TherapyCRYODRESSING INC.KT-10012026-07-31
06973641887146CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.KRP/MYY-M2026-03-12
06973641888518CryoRxChengdu Cryo-push Medical Technology Co.,Ltd.D-KRP/MYY-M2025-09-16
00749756264099DeRoyalDEROYAL INDUSTRIES, INC.T5030NS-102016-09-12
00749756264112DeRoyalDEROYAL INDUSTRIES, INC.T5030ST-102016-09-12
00749756264266DeRoyalDEROYAL INDUSTRIES, INC.T5033NS-102016-09-12
00749756264280DeRoyalDEROYAL INDUSTRIES, INC.T5033ST-102016-09-12
00749756350013DeRoyalDEROYAL INDUSTRIES, INC.T5125ST2019-11-09
00749756350020DeRoyalDEROYAL INDUSTRIES, INC.T5135ST2019-11-09
00749756351966DeRoyalDEROYAL INDUSTRIES, INC.T735NS-BULK2020-02-06
00749756865814DeRoyalDEROYAL INDUSTRIES, INC.T5035NS-102016-09-12
00749756865838DeRoyalDEROYAL INDUSTRIES, INC.T5035ST-102016-09-12
00749756865913DeRoyalDEROYAL INDUSTRIES, INC.T5036NS-102016-09-12
00749756865937DeRoyalDEROYAL INDUSTRIES, INC.T5036ST-102016-09-12
00749756865968DeRoyalDEROYAL INDUSTRIES, INC.T5025ST-102016-09-12
00749756865975DeRoyalDEROYAL INDUSTRIES, INC.T5025NS-102016-09-12
00749756868273DeRoyalDEROYAL INDUSTRIES, INC.T5035NS-L-102016-09-12
00749756868280DeRoyalDEROYAL INDUSTRIES, INC.T5036NS-L-102016-09-12
00749756868297DeRoyalDEROYAL INDUSTRIES, INC.T5035ST-L-102016-09-12
00749756868303DeRoyalDEROYAL INDUSTRIES, INC.T5036ST-L-102016-09-12
00749756869324DeRoyalDEROYAL INDUSTRIES, INC.T5015NS-102016-09-12
00749756869348DeRoyalDEROYAL INDUSTRIES, INC.T5015ST-102016-09-12
00749756869362DeRoyalDEROYAL INDUSTRIES, INC.T5055NS-102016-09-12
00749756869386DeRoyalDEROYAL INDUSTRIES, INC.T5055ST-102016-09-12
00749756869409DeRoyalDEROYAL INDUSTRIES, INC.T5075NS-102016-09-12
00749756869423DeRoyalDEROYAL INDUSTRIES, INC.T5075ST-102016-09-12
00749756869447DeRoyalDEROYAL INDUSTRIES, INC.T5085NS-102016-09-12
00749756869461DeRoyalDEROYAL INDUSTRIES, INC.T5085ST-102016-09-12
00749756879019DeRoyalDEROYAL INDUSTRIES, INC.T5037NS-102016-09-12
00749756879088DeRoyalDEROYAL INDUSTRIES, INC.T5037NS-L-102016-09-12
00749756879101DeRoyalDEROYAL INDUSTRIES, INC.T5037ST-102016-09-12
00749756879125DeRoyalDEROYAL INDUSTRIES, INC.T5037ST-L-102016-09-12
00850080467077ULTRAICEULTRA PAIN PRODUCTS INCUIB-00402026-04-09
00850080467084ULTRAICEULTRA PAIN PRODUCTS INCUIK-00302026-04-09
00850080467091ULTRAICEULTRA PAIN PRODUCTS INCUIS-00602026-04-09
00850080467107ULTRAICEULTRA PAIN PRODUCTS INCUIS-00502026-04-09
00850080467114ULTRAICEULTRA PAIN PRODUCTS INCUIA-00702026-04-09
00850080467121ULTRAICEULTRA PAIN PRODUCTS INCUIC-00802026-04-09
10615089310147Accessory; HTP-1500 Replacement CapADROIT MEDICAL SYSTEMS, INC.HTP-1500 Replacement Cap2024-12-17
00052062000214Polar ProductsPolar Products, Inc.#FB-LG2024-09-30
00052062000238Polar ProductsPolar Products, Inc.#RB2024-09-30
00052062003833Polar ProductsPolar Products, Inc.AIS3.0-92024-09-30
00052062003840Polar ProductsPolar Products, Inc.AIS3.0-162024-09-30
00052062003963Polar ProductsPolar Products, Inc.#BB2024-09-30
00052062003970Polar ProductsPolar Products, Inc.#FMB2024-09-30
00052062003987Polar ProductsPolar Products, Inc.#HC2024-09-30
00052062003994Polar ProductsPolar Products, Inc.#HCL2024-09-30
00052062004007Polar ProductsPolar Products, Inc.#KB2024-09-30
00052062004014Polar ProductsPolar Products, Inc.#LB2024-09-30
00052062004021Polar ProductsPolar Products, Inc.#SB2024-09-30
00052062004038Polar ProductsPolar Products, Inc.#UB2024-09-30
00052062004076Polar ProductsPolar Products, Inc.#UB+SAW2024-09-30
00052062004397Polar ProductsPolar Products, Inc.#KBFULL2024-09-30
00052062004632Polar ProductsPolar Products, Inc.#RBFULL2024-09-30
00052062004694Polar ProductsPolar Products, Inc.#FBN2024-09-30
00052062004700Polar ProductsPolar Products, Inc.#HWB2024-09-30
00052062004830Polar ProductsPolar Products, Inc.#HP2024-09-30
00860008048301AqueCoolAdvanced Ambulatory, Inc.1.02024-07-19
00749756395373DeRoyalDEROYAL INDUSTRIES, INC.13-809A-012024-07-03
04250387101647HILOTHERM HomecareHilotherm GmbHHTP1 Pro2024-05-21
00850016589408Top Shelf OrthopedicsTop Shelf Manufacturing, LLC5082002024-03-18
00850016589415Top Shelf OrthopedicsTop Shelf Manufacturing, LLC5082012024-03-18
00850016589422Top Shelf OrthopedicsTop Shelf Manufacturing, LLC5082022024-03-18
08050593470034CB240_AuroraNEURON GUARD SRLCB240A2024-03-15
10615089109109Soft-TempADROIT MEDICAL SYSTEMS, INC.CA-12019-10-04
10615089310109HTP1500ADROIT MEDICAL SYSTEMS, INC.HTP15002016-09-23
10615089310307Accessory; HTP1500 ADROIT MEDICAL SYSTEMS, INC.IVPB-HTP15002019-10-04
10615089310505Mobile IceADROIT MEDICAL SYSTEMS, INC.MI-122019-10-04
10615089310901Accessory; HTP1500 Bed BracketADROIT MEDICAL SYSTEMS, INC.Bed Bracket2019-10-04
10615089311106HTP1500ADROIT MEDICAL SYSTEMS, INC.HTPS15002019-10-04
10615089311601HTP1500 AccessoryADROIT MEDICAL SYSTEMS, INC.TFR-12019-10-04
10615089620109Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-H12019-10-04
10615089620208Soft-TempADROIT MEDICAL SYSTEMS, INC.ST-H22019-10-04
10885632112690MedichoiceOWENS & MINOR DISTRIBUTION, INC.HTP5002016-08-20