FDA.reportPublic FDA data

M-Brace Air

Primary DI
05391512280451
Brand
M-Brace Air
Company
INDACO SRL
Model
75 M
Catalog number
75
Device description
The Knee Brace # 75 Artemis Light MCL-LCL Instability is for both right and left knees providing optimal support and protection following muscle, joint and/or tendon injuries, LCL MCL weakness. It is constructed exclusively from breathable hypoallergenic fabrics (neoprene and latex free), the area which comes into contact with the skin is made of soft 100% cotton. An exclusive handy locking system allows the required pressure to be varied in two different areas - 2 molded aluminum hinges (lateral and medial) for optimal lateral support- 2 low profile 2mm super light rods, to keep the brace in place during compression therapy.Indications° Traumatic pathologies: light distortions, light articularlaxity, bursitis, articular effusion.° Rehab phase: passive support during rehab, lightprotection during sports.° Offers compression and slight re- alignment in thepresence of mild osteorthratis° Anatomically shaped medial and lateral aluminumpolycentric hinges guarantee a complete synchronywith the natural movement of the knee.° Breathable, 100% cotton on your skin.
Published
2024-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITQJoint, Knee, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391512285371PackageGS110In Commercial Distribution
05391512280451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391512285371053915122853715391512285371
05391512280451053915122804515391512280451

GMDN Terms#

Term, Definition table
TermDefinition
Knee support orthosisA stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-866-374-4050contact@m-brace.com

Regulatory Flags#

DUNS number
338470646
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391512281021M-Brace Air576 S5762024-02-15
05391512281038M-Brace Air576 M5762024-02-15
05391512281045M-Brace Air576 L5762024-02-15
05391512281052M-Brace Air576 XL5762024-02-15
05391512281441M-Brace Air576 XXL5762024-02-15
05391512282905HPH Corp.648K size 26648K2024-04-04
05391512282912HPH Corp.648K size 28648K2024-04-04
05391512282929HPH Corp.648K size 30648K2024-04-04
05391512282936HPH Corp.648K size 32648K2024-04-04
05391512282943HPH Corp.648K size 34648K2024-04-04
05391512282950HPH Corp.648K size 36648K2024-04-04
05391512282967HPH Corp.648K size 38648K2024-04-04
05391512282974HPH Corp.648K size 40648K2024-04-04
05391512282981HPH Corp.648K size 42648K2024-04-04
05391512282998HPH Corp.648K size 44648K2024-04-04
05391512283001HPH Corp.648K size 46648K2024-04-04
05391512283018HPH Corp.648K size 48648K2024-04-04
05391512283025HPH Corp.648K size 50648K2024-04-04
05391512283032HPH Corp.648K size 52648K2024-04-04
05391512283049HPH Corp.648K size 54648K2024-04-04

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