FDA.report

Polar Products

Primary DI
00052062000238
Brand
Polar Products
Company
Polar Products, Inc.
Model
#RB
Device description
Active Ice System Rectangular therapy pad
Published
2024-09-30
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

Related Records

Product Codes

CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications

CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00052062000238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00052062000238000520620002380520620002380052062000238

GMDN Terms

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

Regulatory Flags

DUNS number
612767681
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00052062000214Polar Products#FB-LG2024-09-30
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
00052062004007Polar Products#KB2024-09-30
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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