FDA.report

ManaMed

Primary DI
00810113680439
Brand
ManaMed
Company
MANAMED INC
Model
ManaEZ Boot Pediatric - Medium
Catalog number
EZBPEDM
Device description
The ManaEZ Boot Pediatric is a controlled ankle motion (CAM) walking boot for children and are to be worn to help stabilize the foot and ankle after an injury or surgery. ManaEZ Boot Pediatric boots are color coded for an easy size selection. Small: Pink Medium: Yellow Large: Teal Features and Benefits: Rocker bottom to stimulate natural gait Low profile; lightweight Anatomically-shaped plastic uprights to help facilitate a secure fit for children Easy to apply and adjust with a simple strapping and liner system Fits right and left Ideal for: Treatment of stable fractures and ankle sprains, early rehabilitation of a variety of post-surgical and post-trauma indications requiring fixed control
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
00810113680439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113680439008101136804398101136804390810113680439

GMDN Terms

TermDefinition
Cast bootA boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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
00810113682891ManaEZ Ankle 06 Extra SmallManamed, Inc.ITW2025-09-26
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
00810113683126ManaEZ Night Splint, Plantar Fasciitis, SmallManamed, Inc.ITW2025-09-26
00810113683133ManaEZ Night Splint, Plantar Fasciitis, MediumManamed, Inc.ITW2025-09-26
00810113683140ManaEZ Night Splint, Plantar Fasciitis, LargeManamed, Inc.ITW2025-09-26
00810113683324ManaGO71 Ankle Brace Extra LargeManamed, Inc.ITW2025-09-26
00810113683331ManaGO71 Ankle Brace LargeManamed, Inc.ITW2025-09-26
00810113683348ManaGO71 Ankle Brace MediumManamed, Inc.ITW2025-09-26
00810113683355ManaGO71 Ankle Brace SmallManamed, Inc.ITW2025-09-26
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