TM "Rehabilitimed" K-1P M Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" K-1P M Comfort
• Primary DI: 04823097721605
• Version / Model: K-1P M Comfort
• Catalog Number: K-1P M Comfort
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-04
• Public Version: 1
• Public Version Date: 2025-05-12
• Public Version Status: New
• Public Device Record Key: 5b4d31a2-f64f-4630-ba04-0f2b3ef1498c

Device Description

The orthopedic device is graphite in color, the structure is dense, right, it is an elastic circular 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.). Two pairs of lateral spring stiffening ribs allow for moderate support of lateral displacement of the knee joint. The sealed silicone ring ensures fixation of the knee joint and the correct position of the patella, the reinforcing insert with tightening above and below the ring creates additional stabilization on the lateral and medial sides of the joint.

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
ITM	Cage, Knee	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	04823097721605	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): 34-37