FDA.reportPublic FDA data

ManaMed

Primary DI
00810113682402
Brand
ManaMed
Company
Manamed, Inc.
Model
ManaEZ Ice Compression Wrap Knee
Catalog number
EZCPWK01
Device description
Quick fitting, universal, knee brace. Quick inflation system that's easy to use.
Published
2022-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube
ITQJoint, Knee, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810113682402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113682402008101136824028101136824020810113682402

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid thermal/compression therapy system control unitA mains electricity (AC-powered) device intended to pump heated and/or cooled water through an externally applied wrap (not included), and to air inflate the wrap, for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury and/or orthopaedic surgery (e.g., pain, swelling, inflammation). It includes a fluid pump, air pump, controls, and either a heater or a means for cold therapy (e.g., refrigeration unit, addition of independently cooled ice water) or both. The unit may be programmable for selected treatment plans. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-508-0712support@manamed.com

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050289252HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
06959557201382Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-15
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.IRP2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.IRP2026-10-12
06976331781397AnacondafightwearHuizhou XINYI Technology Co., LTDIRP2026-10-12
06959557201375Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-10
00810179882389CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882396CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882419CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882426CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882488CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882495CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882501CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882624CopperfitIdeavillage Products CorpITQ2026-10-01
00810179882631CopperfitIdeavillage Products CorpITQ2026-10-01
06959557200286Powered Inflatable Tube MassagerSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-09-30
06974000130033HealthpalXiamen Healthpal Electronic Co., Ltd.IRP2026-08-26
00810226441538ViveVIVE HEALTH LLCITQ2026-08-03
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.IRP2026-07-31