TM "Rehabilitimed" K-1 XXXL Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" K-1 XXXL Comfort
• Primary DI: 04823097717875
• Version / Model: K-1 XXXL Comfort
• Catalog Number: K-1 XXXL Comfort
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-03
• Public Version: 1
• Public Version Date: 2025-05-12
• Public Version Status: New
• Public Device Record Key: 724a79ec-af6c-423c-ab9b-026611d977bb

Device Description

The orthopedic device is graphite in color, it is an orthosis for the knee joint made of multilayer material with an inner layer of 100% cotton fabric, equipped with monocentric hinges located on the side surfaces and two parallel straps with textile fasteners in the lower third of the thigh and upper third of the shin. The orthosis provides external semi-rigid fixation of the knee joint, unloading its capsular ligamentous apparatus and stabilizing the patella.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITQ	Joint, Knee, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41065	Knee support orthosis	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097717875	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Mid-knee circumference in standing position (cm): 55-60