Guardian Supporter

Basic Information

• Brand Name: Guardian Supporter
• Primary DI: 08809818038074
• Version / Model: GAK-S
• Company Name: BM KOREA CO., LTD
• Labeler DUNS: 557799209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-20
• Public Version: 1
• Public Version Date: 2025-03-28
• Public Version Status: New
• Public Device Record Key: 170c9f0e-0b31-4ad1-8597-d30574717eda

Device Description

This product is a device designed to provide support by compressing and immobilizing certain parts of the body (such as the waist, knees, wrists, or back); products that do not offer support or stabilization are excluded.

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: 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
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64398	Thoracic cage orthosis force meter	An electronic device designed to measure the force on the compression plate of a thoracic cage orthosis when worn by a patient, or to estimate thoracic elasticity prior to applying a thoracic cage orthosis. These measurements are used to facilitate decisions about the modification of custom treatment parameters. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809818038074	GS1

Device Sizes

Type	Value	Unit	Text
Length	155	Millimeter
Width	250	Millimeter