Konmed

Basic Information

• Brand Name: Konmed
• Primary DI: 06970935830505
• Version / Model: KM-F-58
• Company Name: Shenzhen Konmed Technology Co., Ltd.
• Labeler DUNS: 544436531
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-24
• Public Version: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 68ff0c70-6ada-4a4c-829b-68011e5646e8

Device Description

It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustable by customer desired with below feature: - The half-hard design at the bottom of the device and adjust and swing according to human walking habit, while the thin and soft design make it easy to wear and can help to recovery and satisfy patient’sdemand - The hollow designing on the heel part is good to wear - The cushion on the shin and shank can be disassembled, which is convenient to wash and good to maintain hygienic - With left and right design difference - The tiptoe part can be trimmed based on your size - The “8” shape straps is detachable

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
61652	Tubular support bandage, non-latex, reusable	A tubular, elastic non-latex fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970935830505	GS1