Knee Brace

GUDID 16974500613576

Adjustable Knee Brace Materials: Nylon, Neoprene Size: One Size,fits left and right Knee

GCMEDICA ENTERPRISE LTD.(WUXI)

Knee support orthosis

• Primary Device ID: 16974500613576
• NIH Device Record Key: 63911aa8-62de-491e-8a87-148589652daa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Knee Brace
• Version Model Number: JP04A01
• Company DUNS: 560122957
• Company Name: GCMEDICA ENTERPRISE LTD.(WUXI)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974500613579 [Primary]
GS1	16974500613576 [Package]; Contains: 06974500613579; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• ITQ: Joint, Knee, External Brace

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-22
• Device Publish Date: 2025-12-12

On-Brand Devices [Knee Brace]

• 16974500613583: Adjustable Knee Brace Materials: Polyester, Rubber fibers Size: L/XL,fits left and right Knee
• 16974500613576: Adjustable Knee Brace Materials: Nylon, Neoprene Size: One Size,fits left and right Knee