TM "Rehabilitimed" K-1-PSH L-XL Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" K-1-PSH L-XL Comfort
• Primary DI: 04823097721360
• Version / Model: K-1-PSH L-XL Comfort
• Catalog Number: K-1-PSH L-XL 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: f87b8bbb-02cd-4c0d-a35e-8496a59f09b1

Device Description

The orthopedic device is graphite in color, has a dense structure, is a knee joint orthosis made of aeroprene (aeroprene is a soft, breathable, highly elastic neoprene that has additional perforations over the entire surface, which enhances air and moisture exchange). Equipped with two lateral biomechanical stiffening ribs that provide a strong degree of fixation, lateral stabilization and relief of the knee joint. A silicone roller-ring sewn inside the knee pad stabilizes the kneecap in an anatomically correct position, reduces pain and provides additional protection of the joint from the front.

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	04823097721360	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): 38-45