ManaMed - The ManaEZ Rom Elite adjustable knee brace allows - MANAMED INC

Duns Number:084042331

Device Description: The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the bra The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the brace for custom fitting. This product is ideal for knee ligament damage, knee surgeries, and instability of the knee. The ManaEZ Rom Elite is designed for post-operative fixation, allowing the doctor to lock the patient into extension and control range of motion as prescribed. ManaEZ ROM Elite is a quick fitting, universal, telescoping, and drop lock post op knee brace. The brace has a unique malleable bar system to conform to all shapes and sizes.-Telescoping and malleable hinge bars extendable from 16.5" - 27" (42cm - 68.5cm)-Hinge range of motion adjustment: Flexion (0° - 120°) and extension (0° - 90°)-Quick lock key offers ability to control and lock out the hinge motion to 0°, 15°, and 30° directly-Lightweight, latex free breathable material-Easy application, universal size with hook and buckle closure, design fits either leg

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More Product Details

Catalog Number

EZRS1833

Brand Name

ManaMed

Version/Model Number

ManaEZ ROM Elite Short

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

ITQ

Product Code Name

Joint, Knee, External Brace

Device Record Status

Public Device Record Key

5dc0f5ea-0dfe-4e48-8af6-3f1082b5b96f

Public Version Date

August 30, 2022

Public Version Number

2

DI Record Publish Date

June 21, 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