Polar Products

Primary DI
00052062004007
Brand
Polar Products
Company
Polar Products, Inc.
Model
#KB
Device description
Active Ice System Knee and Joint therapy pad
Published
2024-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00052062004007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00052062004007000520620040070520620040070052062004007

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
612767681
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00052062000214Polar Products#FB-LG2024-09-30
00052062000238Polar Products#RB2024-09-30
00052062003833Polar ProductsAIS3.0-92024-09-30
00052062003840Polar ProductsAIS3.0-162024-09-30
00052062003963Polar Products#BB2024-09-30
00052062003970Polar Products#FMB2024-09-30
00052062003987Polar Products#HC2024-09-30
00052062003994Polar Products#HCL2024-09-30
00052062004014Polar Products#LB2024-09-30
00052062004021Polar Products#SB2024-09-30
00052062004038Polar Products#UB2024-09-30
00052062004076Polar Products#UB+SAW2024-09-30
00052062004397Polar Products#KBFULL2024-09-30
00052062004632Polar Products#RBFULL2024-09-30
00052062004694Polar Products#FBN2024-09-30
00052062004700Polar Products#HWB2024-09-30
00052062004830Polar Products#HP2024-09-30

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Primary DI, Brand, Company table
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20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
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00812120001436Game Ready Left Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
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00812120001542Game Ready Articulated Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001566Game Ready Ankle Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
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