Digital Knee®

GUDID 09413000123395

Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.

OPUM TECHNOLOGIES SERVICES LIMITED

Electronic goniometer/kinesiology sensor

• Primary Device ID: 09413000123395
• NIH Device Record Key: ab822a0c-e4c5-42cd-a1ae-55ed23077795
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Knee®
• Version Model Number: DK-017-L
• Company DUNS: 758645625
• Company Name: OPUM TECHNOLOGIES SERVICES LIMITED
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09413000123395 [Primary]

FDA Product Code

• KQX: Goniometer, Ac-Powered

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: 2025-01-23
• Device Publish Date: 2025-01-15

On-Brand Devices [Digital Knee®]

• 09413000113839: Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion d
• 09413000123418: Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion d
• 09413000123395: Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion d