FDA.reportPublic FDA data

M-Brace Air

Primary DI
05391512285111
Brand
M-Brace Air
Company
INDACO SRL
Model
17 M
Catalog number
17
Device description
The Salto Ankle Stabilizer Brace is made with an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as the use of a unique construction technology, this innovative ankle stabilizer combines the ease of use of a mass-produced item with the effectiveness of a taping bandage. It is the only ankle brace with a posterior opening, allowing easy and painless application The brace offers a constant control of the inversion and eversion degree. Far from being cumbersome, it can easily fit any shoe and can be worn on either foot. INDICATIONS • Traumatic pathologies: distortions – tendonitis – luxations. • Rehab phase: passive support for the ankle functional rehab, it controls inversion and eversion movements of the ankle.
Published
2024-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITWJoint, Ankle, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391512285111PackageGS112In Commercial Distribution
05391512280192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391512285111053915122851115391512285111
05391512280192053915122801925391512280192

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-374-4050contact@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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