FDA.reportPublic FDA data

Unite Medical®

Primary DI
00850012035138
Brand
Unite Medical®
Company
Unite Medical, LLC
Model
Deluxe Universal ROM Knee Brace
Catalog number
KO3233-1
Device description
The Unite Medical® Deluxe Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.
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
00850012035138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012035138008500120351388500120351380850012035138

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
00850012035244Unite Medical®Single Upright Knee Orthosis (Left, Universal)KO4351L2023-12-28
00850012035251Unite Medical®Single Upright Knee Orthosis (Right, Universal)KO4351R2023-12-28

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