FDA.reportPublic FDA data

ManaMed

Primary DI
00810113680538
Brand
ManaMed
Company
MANAMED INC
Model
ManaEZ Hinged Knee Brace Small
Catalog number
EZHK1820S
Device description
The ManaEZ Hinged Knee is a convenient wrap on hinged sleeve. The open popliteal feature allows for a comfortable fit. Wrap feature for easy on and off application High quality neoprene Open popliteal
Published
2022-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITQJoint, Knee, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810113680538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113680538008101136805388101136805380810113680538

GMDN Terms#

Term, Definition table
TermDefinition
Knee orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
084042331
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850998008102ManaMed PlasmaWave Standard Calf SleeveM-402024-05-31
00810113681092ManaMed IncPlasmaWave Calf SleeveM-422022-12-30
00810113683218ManaMedManaflexx 2 OTCMF002-OTC2024-04-30
00850998008089ManaMedManaflexx2MF002-RX2024-04-30
00850998008423ManaMedManaflexx2 Replaceable PadMFPAD2024-04-30
00850998008904ManaMedManaFlow ExtendersMFLOWEXT2024-04-30
00810113682655ManaMed IncManaCold Platinum Ankle PadMCOLDPAD-ANKLE2023-08-28
00810113682662ManaMed IncManaCold Platinum Back PadMCOLDPAD-BACK2023-08-28
00810113682679ManaMed IncManaCold Platinum Hip PadMCOLDPAD-HIP2023-08-28
00810113682785ManaMedManaMed Air Customizable Tall Extra SmallMACAIR01-XS2023-08-28
00810113682792ManaMedManaMed Air Customizable Tall SmallMACAIR01-S2023-08-28
00810113682808ManaMedManaMed Air Customizable Tall MediumMACAIR01-M2023-08-28
00810113682815ManaMedManaMed Air Customizable Tall Large MACAIR01-L2023-08-28
00810113682822ManaMedManaMed Air Customizable Tall Extra LargeMACAIR01-XL2023-08-28
00810113682839ManaMedManaMed Air Customizable Short Extra SmallMACAIR01-S-XS2023-08-28
00810113682846ManaMedManaMed Air Customizable Short SmallMACAIR01-S-S2023-08-28
00810113682853ManaMedManaMed Air Customizable Short MediumMACAIR01-S-M2023-08-28
00810113682860ManaMedManaMed Air Customizable Short LargeMACAIR01-S-L2023-08-28
00810113682877ManaMedManaMed Air Customizable Short Extra LargeMACAIR01-S-XL2023-08-28
00810113682631ManaMed IncKangaroo Sling PillowKSS001-P2023-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810113579665ViveVIVE HEALTH LLCITQ2026-02-09
00810113579672ViveVIVE HEALTH LLCITQ2026-02-09
00810113579689ViveVIVE HEALTH LLCITQ2026-02-09
00810113579696ViveVIVE HEALTH LLCITQ2026-02-09
00810179882440CopperFitIdeavillage Products CorpITQ2026-01-13
16974500613576Knee BraceGCMEDICA ENTERPRISE LTD.(WUXI)ITQ2025-12-12
16974500613583Knee braceGCMEDICA ENTERPRISE LTD.(WUXI)ITQ2025-12-12
00810113683065ManaEZ ROM Ice ShortManamed, Inc.ITQ2025-10-17
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.ITQ2025-10-03
00636257207727MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207734MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207741MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207758MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207765MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207772MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207789MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
06971503604528comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.ITQ2025-08-28
00190446660453PROCAREDJO, LLCITQ2025-07-23
00749756395489DeRoyalDEROYAL INDUSTRIES, INC.ITQ2025-07-23
00819567017891ComfytopiaComfytopia, Inc.ITQ2025-07-09
00819567017907ComfytopiaComfytopia, Inc.ITQ2025-07-09
00854194003138ComfytopiaComfytopia, Inc.ITQ2025-07-09
10810113579891ViveVIVE HEALTH LLCITQ2025-07-08
10810113579907ViveVIVE HEALTH LLCITQ2025-07-08
10810113579914ViveVIVE HEALTH LLCITQ2025-07-08
10810113579921ViveVIVE HEALTH LLCITQ2025-07-08
00810113579931ViveVIVE HEALTH LLCITQ2025-07-08
10810113579945ViveVIVE HEALTH LLCITQ2025-07-08
10810113579952ViveVIVE HEALTH LLCITQ2025-07-08
00190446660545PROCAREDJO, LLCITQ2025-07-07