FDA.reportPublic FDA data

Unite Medical®

Primary DI
00850012035503
Brand
Unite Medical®
Company
Unite Medical, LLC
Model
Ankle Foot Orthosis (Right,Large)
Catalog number
AFO0671R-L
Device description
The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic ankle sprains, hind foot arthritis, ankle tendonitis, and ankle arthritis. The ankle foot orthosis is a lightweight, low profile brace, great for extended wear.
Published
2023-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00850012035503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012035503008500120355038500120355030850012035503

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
833.868.6483info@unitemedical.net

Regulatory Flags#

DUNS number
117553945
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
00850063323550RegeniCool™ ProRC-PRO-1000RC-PRO-10002026-03-13
00850063323567RegeniCool™ ProRC-PRO-1000RC-PRO-10002026-03-13
00850012035312Unite Medical®Cryo Pneumatic Shoulder - UniversalCyro36702024-06-20
00850012035619Unite Medical®Heel Stabilizer (Small)HS3170-S2023-12-28
00850012035626Unite Medical®Heel Stabilizer (Medium)HS3170-M2023-12-28
00850012035633Unite Medical®Heel Stabilizer (Large)HS3170-L2023-12-28
00850012035640Unite Medical®Heel Stabilizer (XLarge)HS3170-XL2023-12-28
00850052096915Unite Medical®Tall Walking Boot - Pneumatic (XSmall)PWB6061-XS-T2024-06-20
00850052096922Unite Medical®Tall Walking Boot - Pneumatic (Small)PWB6061-S-T2024-06-20
00850052096939Unite Medical®Tall Walking Boot - Pneumatic (Medium)PWB6061-M-T2024-06-20
00850052096946Unite Medical®Tall Walking Boot - Pneumatic (Large)PWB6061-L-T2024-06-20
00850052096953Unite Medical®Tall Walking Boot - Pneumatic (XLarge)PWB6061-XL-T2024-06-20
00850063323000Unite Medical®Short Walking Boot - Pneumatic (XLarge)PWB6061-XL-S2024-06-20
00850063323017Unite Medical®Short Walking Boot - Pneumatic (Large)PWB6061-L-S2024-06-20
00850063323024Unite Medical®Short Walking Boot - Pneumatic (Medium)PWB6061-M-S2024-06-20
00850063323031Unite Medical®Short Walking Boot - Pneumatic (Small)PWB6061-S-S2024-06-20
00850063323048Unite Medical®Short Walking Boot - Pneumatic (XSmall)PWB6061-XS-S2024-06-20
00850012035121Unite Medical®Universal ROM Knee BraceKO32332023-12-28
00850012035138Unite Medical®Deluxe Universal ROM Knee BraceKO3233-12023-12-28
00850012035244Unite Medical®Single Upright Knee Orthosis (Left, Universal)KO4351L2023-12-28

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