POD Active Knee Brace

Basic Information

• Brand Name: POD Active Knee Brace
• Primary DI: 09344006000406
• Version / Model: K4 2.0
• Company Name: POD ACTIVE PTY LTD
• Labeler DUNS: 759177843
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-29
• Public Version: 3
• Public Version Date: 2022-08-30
• Public Version Status: Update
• Public Device Record Key: f2f6b820-df8c-4c75-b230-974da60e621b

Device Description

POD Active Knee Brace; model K4; version 2.0; single (LT or RT)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: 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
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	09344006000406	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3X+
Device Size Text, specify			XS/SM
Device Size Text, specify			MD/LG
Device Size Text, specify			XL/XXL