myDigitalKnee®

GUDID 09413000126259

myDigitalKnee mobile app is used with a Digital Knee sensor 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: 09413000126259
• NIH Device Record Key: a1301cd7-24ef-490f-b22c-1a61ef2ce0f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myDigitalKnee®
• Version Model Number: Mobile App iOS
• 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: false
• 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	09413000126259 [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: 2025-04-02
• Device Publish Date: 2025-03-25

On-Brand Devices [myDigitalKnee®]

• 09413000126273: myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and
• 09413000126259: myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and