ManaMed - The ManaEZ Boot Pediatric is a controlled ankle - MANAMED INC

Duns Number:084042331

Device Description: The ManaEZ Boot Pediatric is a controlled ankle motion (CAM) walking boot for children and 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: PinkMedium: YellowLarge: TealFeatures and Benefits:Rocker bottom to stimulate natural gaitLow profile; lightweightAnatomically-shaped plastic uprights to help facilitate a secure fit for childrenEasy to apply and adjust with a simple strapping and liner systemFits right and leftIdeal for: Treatment of stable fractures and ankle sprains, early rehabilitation of a variety of post-surgical and post-trauma indications requiring fixed control

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More Product Details

Catalog Number

EZBPEDS

Brand Name

ManaMed

Version/Model Number

ManaEZ Boot Pediatric - Small

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ITW

Product Code Name

Joint, Ankle, External Brace

Device Record Status

Public Device Record Key

f9b2cf08-4a7c-4013-8830-947192759c1e

Public Version Date

June 28, 2022

Public Version Number

1

DI Record Publish Date

June 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MANAMED INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 128
2 A medical device with a moderate to high risk that requires special controls. 19