ComfyHealth

Basic Information

• Brand Name: ComfyHealth
• Primary DI: 04719879641875
• Version / Model: SE23
• Company Name: Comfy Health Group Co., Ltd.
• Labeler DUNS: 658202517
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-10
• Public Version: 1
• Public Version Date: 2025-07-18
• Public Version Status: New
• Public Device Record Key: dd03bd1b-234e-4db1-ab9e-07cc9d17f690

Device Description

BRACOO SE23 Waist trimmer Wrap Comfort Fit & Wicking Performance Black SIZE:L/XL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: 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	04719879641875	GS1