M-Brace Air

Primary DI
05391512286873
Brand
M-Brace Air
Company
INDACO SRL
Model
139 E
Catalog number
139
Device description
This Epicondylitis Brace (Tennis / Golfers Elbow brace) has been designed and produced as a support and protective device for tendon and joint inflammations either caused by trauma, stress or excessive fatigue. For the development of this device, two special fabrics have been matched: • The inside fabric is made from a soft breathable microfiber, extremely comfortable to the skin. • The fabric on the outside, made with a particular and dense nylon mesh forming microscopic and resistant loops, allows the Velcro to securely fasten on the surface. Due to the specific construction, this brace can be worn and positioned very easily. The tension should be adjusted taking care not to slow down the normal circulation of blood. The pressure of the inside pad, which needs to be positioned immediately below the insertion of the tendon, relieves pain by diminishing the stress on muscles, tendons and ligaments.
Published
2024-02-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391512286873PackageGS124In Commercial Distribution
05391512281939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391512286873053915122868735391512286873
05391512281939053915122819395391512281939

GMDN Terms#

Term, Definition table
TermDefinition
Elbow orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8663744050contact@m-brace.com

Regulatory Flags#

DUNS number
338470646
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

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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