FDA.reportPublic FDA data

Unite Medical®

Primary DI
00850012035251
Brand
Unite Medical®
Company
Unite Medical, LLC
Model
Single Upright Knee Orthosis (Right, Universal)
Catalog number
KO4351R
Device description
The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A single lateral upright design in conjunction with flex-hinge to unload the medial compartment of the knee, helps to promote normal joint movement and reduce pain.
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
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
00850012035251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012035251008500120352518500120352510850012035251

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.

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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