ManaMed - ManaOA is a lightweight, low-profile single - MANAMED INC

Duns Number:084042331

Device Description: ManaOA is a lightweight, low-profile single upright osteoarthritis knee brace with unique ManaOA is a lightweight, low-profile single upright osteoarthritis knee brace with unique varus/valgus angle adjustment to optimize pain relief. Laterally applied frame and hinge corrects for either medial or lateral compartment and avoids contralateral limb contact during walking.Indication:Mild to severe unicompartmental osteoarthritis,Medial or lateral compartmentFeatures & Benefits:Single upright OA brace.Set-Fit Buckle System that eliminates the hassle of Velcro® adjustments.Maximized 3 points of leverage for medical compartment.Q-Hinge corrects by changing the overall angle of the brace rather than pushing or pulling with the straps or condyle pads.Available in heavy-duty Q-hinge for patients over 300 pounds.

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More Product Details

Catalog Number

MFORCEOA1R

Brand Name

ManaMed

Version/Model Number

ManaForceOA, RGT

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"

Yes

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

71091add-3e04-411f-a1f0-f744b19d62a9

Public Version Date

August 30, 2022

Public Version Number

2

DI Record Publish Date

June 23, 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