Ankle Support

Basic Information

• Brand Name: Ankle Support
• Primary DI: 06974500613449
• Version / Model: JP02C01
• Company Name: GCMEDICA ENTERPRISE LTD.(WUXI)
• Labeler DUNS: 560122957
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-08
• Public Version: 1
• Public Version Date: 2025-12-16
• Public Version Status: New
• Public Device Record Key: b9eea168-b4ae-47d5-83f4-f53a68ce8ed1

Device Description

Adjustable Fiber Contents: Black Knitting(shell):100%polyester Black knitting(lining):88.5%polyester 11.5%spandex Black tricot(shell):65.4%nylon 34.6%polyester

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
ITW	Joint, Ankle, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32858	Elbow/ankle friction/impact protector	A device designed to be worn over the elbow and/or the ankle to provide a cushion to protect the joint(s) from friction against surfaces and knocks against objects. It is typically made from soft padded materials and held in place with straps; it is designed to cover only the joint(s) and is not intended to cover a larger portion of the arm or leg. It is typically used by persons that have tendencies for skin sores on their elbows, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16974500613446	GS1		12	In Commercial Distribution
Primary	06974500613449	GS1