Comfytopia

Basic Information

• Brand Name: Comfytopia
• Primary DI: 04719879643329
• Version / Model: LE70
• Company Name: Comfytopia, Inc.
• Labeler DUNS: 003944628
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-18
• Public Version: 2
• Public Version Date: 2022-12-13
• Public Version Status: Update
• Public Device Record Key: 91fa506b-2001-4a51-8f22-b3e691e292e4
• Distribution End Date: 2022-11-18

Device Description

BRACOO LE70 Calf Fulcrum Sleeve Comfort Fit Black S/M-size Pair

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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
66085	Multiple-joint lower limb orthosis	A 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 multiple joints of the lower body which will include the knee (e.g., hip and knee, knee and ankle). The device is typically adjustable and articulating. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719879643329	GS1