FDA.reportPublic FDA data

AqueCool

Primary DI
00860008048301
Brand
AqueCool
Company
Advanced Ambulatory, Inc.
Model
1.0
Device description
The AqueCool Device, in conjunction with AqueCool masks, pumps cooled water across recovering tissue to wick away excess heat. The device is controllable between 50 and 65 Degrees Fahrenheit and utilizes a 6 foot tube set to allow the device to remain on the floor while in operation. Simple On/Off power button and temperature control knob on top of device allow user to easily adjust temperature or turn device off. The AqueCool system requires a standard 120VAC wall receptacle and 8-10oz of distilled water to operate.
Published
2024-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008048301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008048301008600080483018600080483010860008048301

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal therapy system control unitAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
165086757
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008048349AqueCool1.02024-07-19
00860008048356AqueCool1.02024-07-19
00860008048363AqueCool1.02024-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063323550RegeniCool™ ProUnite Medical, LLCILO2026-03-13
00850063323567RegeniCool™ ProUnite Medical, LLCILO2026-03-13
06973641886880CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886897CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886903CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886910CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886927CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886934CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886941CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641886958CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887061CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887078CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887085CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887092CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887108CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887115CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887122CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887139CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641887146CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
00850033615616ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UFTHERMOTEK, INC.ILO2026-02-23
00850033615647THERAPY SYSTEM, ARTEK PRO-02THERMOTEK, INC.ILO2026-02-23
00850033615081ThermoTek WRAP, BACK W/BRACE,LSO,ONE-SIZETHERMOTEK, INC.ILO2026-02-21
00850033615104ThermoTek WRAP, KNEE,ROM BRACE, 2XL, 13"THERMOTEK, INC.ILO2026-02-21
00850033615135ThermoTek WRAP, KNEE, ROM BRACE, 3XL, 13"THERMOTEK, INC.ILO2026-02-21
00850033615142ThermoTek WRAP, KNEE, ROM BRACE, L, 13"THERMOTEK, INC.ILO2026-02-21
00850033615159ThermoTek WRAP, FOOT/ANKLE, SPU , UFTHERMOTEK, INC.ILO2026-02-21
00850033615166ThermoTek WRAP, HIP, MED, W/HARNESS, SPU, UFTHERMOTEK, INC.ILO2026-02-21
00850033615173ThermoTek WRAP, HIP, STND, SPU, UNFILLEDTHERMOTEK, INC.ILO2026-02-21
00850033615180ThermoTek WRAP, KNEE, ROM BRACE, M, 13"THERMOTEK, INC.ILO2026-02-21
00850033615197ThermoTek WRAP, KNEE, ROM BRACE, XL, 13"THERMOTEK, INC.ILO2026-02-21