Comfytopia

Basic Information

• Brand Name: Comfytopia
• Primary DI: 04719879641936
• Version / Model: BS80
• 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: 3
• Public Version Date: 2023-05-04
• Public Version Status: Update
• Public Device Record Key: 855d882d-7177-4771-8836-11721d2dc1f4
• Distribution End Date: 2022-11-18

Device Description

BRACOO BS80 Neck Fulcrum Wrap Breathable Gary

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
ISR	Band Or Belt, Pelvic Support	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43527	Static magnetic orthopaedic orthosis	A body-support orthopaedic device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around a body area (e.g., shoulder, elbow, thoracic or lumbar spine region, knee, foot arch) and produce a weak magnetic flux field to assist the whole body’s innate healing capability to alleviate body aches and pains (e.g., from muscle soreness/stiffness, arthritis). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719879641936	GS1