TM "Rehabilitimed" RP-6K-M1 XXL Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" RP-6K-M1 XXL Comfort
• Primary DI: 04823097723630
• Version / Model: RP-6K-M1 XXL Comfort
• Catalog Number: RP-6K-M1 XXL 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: 736b8c0b-818b-47b1-a4e8-c7e66fe0788d

Device Description

The graphite color shoulder brace provides a medium degree of fixation of the elbow joint and shoulder girdle. The arm sleeve is easily unfastened with a textile fastener and provides free access. Equipped with a belt girdling the chest with the arm pressed to the body to fix and prevent the arm from being pulled away.

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
IOY	Support, Arm	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41053	Elbow orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097723630	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			Chest circumference with arm pressed (inch): 39-53