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

Basic Information

• Brand Name: TM "Rehabilitimed" K-1-PSH L-XL Comfort
• Primary DI: 04823097723067
• 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: 2025-05-17
• Public Version: 1
• Public Version Date: 2025-05-26
• Public Version Status: New
• Public Device Record Key: cebe033b-ebaf-45b1-8eea-05ef859eb0a5

Device Description

Detachable knee brace in graphite color, provides external semi-rigid fixation of the knee joint, relieves the capsular ligament apparatus and stabilizes the patella. Equipped with two lateral biomechanical hinged stiffening ribs and a silicone ring sewn inside the bandage to stabilize the patella in an anatomically correct position. Made of aeroprene (aeroprene is a soft, breathable highly elastic neoprene that has additional perforations that enhance air and moisture exchange) and multilayer material with a cotton layer against the body.

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	04823097723067	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 (inch): 15-17,5