FDA.report

ManaMed

Primary DI
00810113680408
Brand
ManaMed
Company
MANAMED INC
Model
ManaEZ Ankle Stirrup Universal
Catalog number
EZAS4350
Device description
This universally sized support brace can be worn on either the left or right foot. It is intended for use after injury and throughout the recovery period. Universally sized Low profile for minimal bulk in shoe Adjustable straps allow left or right usage
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

Related Records

Contact Domains

Product Codes

CodeName
ITWJoint, Ankle, External Brace

Product Code Classifications

CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810113680408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113680408008101136804088101136804080810113680408

GMDN Terms

TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Sterilization Methods

Method

Contacts

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
false
Sterilization required before use
false

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00810113682662ManaMed IncManaCold Platinum Back PadMCOLDPAD-BACK2023-08-28
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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 DIBrandCompanyProduct codePublished
16974500613446Ankle SupportGCMEDICA ENTERPRISE LTD.(WUXI)ITW2025-12-08
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00810113682907ManaEZ Ankle 06 SmallManamed, Inc.ITW2025-09-26
00810113682914ManaEZ Ankle 06 MediumManamed, Inc.ITW2025-09-26
00810113682921ManaEZ Ankle 06 LargeManamed, Inc.ITW2025-09-26
00810113682938ManaEZ Ankle 06 Extra LargeManamed, Inc.ITW2025-09-26
00810113682945ManaEZ Ankle 06 Extra Extra LargeManamed, Inc.ITW2025-09-26
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00810113683133ManaEZ Night Splint, Plantar Fasciitis, MediumManamed, Inc.ITW2025-09-26
00810113683140ManaEZ Night Splint, Plantar Fasciitis, LargeManamed, Inc.ITW2025-09-26
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