Knee Support Orthopedic Knee Brace

Basic Information

• Brand Name: Knee Support Orthopedic Knee Brace
• Primary DI: 00891237001614
• Version / Model: 83101-83106
• Catalog Number: 1614
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Labeler DUNS: 783518983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-07
• Public Version: 4
• Public Version Date: 2022-10-03
• Public Version Status: Update
• Public Device Record Key: f5298ff0-88e9-454c-9522-cd961a3b7f92

Device Description

• Thermal neoprene sleeves • Adjustable VELCRO straps • Fits right or left knee • Rigid uprights for support • Stabilize collateral ligaments • Decreases pain symptoms • Improves joint function • Stabilizes knee joint • Help with Arthritic knee pain

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
IQI	Orthosis, Limb 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
Package	10891237001611	GS1	Outer Case	48	In Commercial Distribution
Primary	00891237001614	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]