FDA.reportPublic FDA data

ManaMed

Primary DI
00850998008980
Brand
ManaMed
Company
Manamed, Inc.
Model
ManaCold
Catalog number
MANACOLD01
Device description
ManaCold Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms after surgery or injury. ManaCold consists of a cold water circulating unit, a 9 quart cooling reservoir with a lid, 7 foot insulation tube and a cold therapy pad. The cold therapy pad is applied to a patients injured area, delivering cold therapy through the tubing and into the cold pad.Commonly used following knee surgery, shoulder surgery or back surgeryManaCold can be used and operated by a patient or healthcare provider in a home or clinical setting
Published
2022-06-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00850998008980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850998008980008509980089808509980089800850998008980

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid thermal therapy systemAn assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs (e.g., anatomically specific wraps), and a mains electricity (AC-powered) fluid pump and heating/cooling unit with controls/display; the device is not intended for wrap inflation. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
084042331
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810113682730ManaSlideMSLIDEMSLIDE012025-11-25
00810113688473ManaMed IncManaMed Ultrasound Coupling GelMANAGEL012022-12-31
00810113684154ManaEZ Wrist Left, Extra Large EZW3908L-XLEZW3908L-XL2025-10-17
00810113684161ManaEZ Wrist Left, Extra SmallEZW3908L-XSEZW3908L-XS2025-10-17
00810113684178ManaEZ Wrist Right, Extra Large EZW3908R-XLEZW3908R-XL2025-10-17
00810113684185ManaEZ Wrist Right, Extra SmallEZW3908R-XSEZW3908R-XS2025-10-17
00810113682969"ManaEZ Single Panel Knee Immobilizer 18"""EZIMM01-18EZIMM01-182025-11-25
00810113682976"ManaEZ Single Panel Knee Immobilizer 20"""EZIMM01-20EZIMM01-202025-11-25
00810113682983"ManaEZ Single Panel Knee Immobilizer 24"""EZIMM01-24EZIMM01-242025-11-25
00810113682990"ManaEZ 3 Panel Knee Immobilizer 18"""EZ3PIMM01-18EZ3PIMM01-182025-11-25
00810113683003"ManaEZ 3 Panel Knee Immobilizer 20"""EZ3PIMM01-20EZ3PIMM01-202025-11-25
00810113683010"ManaEZ 3 Panel Knee Immobilizer 24"""EZ3PIMM01-24EZ3PIMM01-242025-11-25
00810113683294"ManaEZ 3 Panel Knee Immobilizer 16"""EZ3PIMM01-16EZ3PIMM01-162025-11-25
00810113682600ManaMed IncManaEZ Ice Wrist EZIWST012022-10-13
00850998008119ManaMedManaEZ Wrist Universal RightEZW3908R2022-06-20
00850998008126ManaMedManaEZ Wrist Universal LeftEZW3908L2022-06-20
00810113683065ManaEZ ROM Ice ShortEZR001-XSMEZR001-XSM2025-10-17
00810113683515ManaEZ Hip Ice CureTechEZHIP01B-CTEZHIP01B-CT2025-10-03
00810113683522ManaEZ ROM Ice CureTechEZR001-CTEZR001-CT2025-10-03
00810113683539ManaEZ Shoulder Ice CureTechEZSHLD-CTEZSHLD-CT2025-10-03

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Primary DI, Brand, Company table
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06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880772Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880789Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
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06973641880826Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
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00197344214740MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
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00197344214733MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-08
06973641887146CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641888518CryoRxChengdu Cryo-push Medical Technology Co.,Ltd.ILO2025-09-16
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00810041987617ViveVIVE HEALTH LLCILO2024-07-17
10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350110T/PadC2DX, INC.ILO2024-01-09
00810041981523ViveVIVE HEALTH LLCILO2023-08-07
08809802644038CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644045CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
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