Digital Knee®

Basic Information

• Brand Name: Digital Knee®
• Primary DI: 09413000123418
• Version / Model: DK-017-R
• Company Name: OPUM TECHNOLOGIES SERVICES LIMITED
• Labeler DUNS: 758645625
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-15
• Public Version: 1
• Public Version Date: 2025-01-23
• Public Version Status: New
• Public Device Record Key: cfc8f138-114f-4d12-9d6c-209061620e4e

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
KQX	Goniometer, Ac-Powered	Orthopedic	888.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33652	Electronic goniometer/kinesiology sensor	A small electronic device designed to be fastened to a body part (e.g., a patient worn goniometer-, accelerometer-, or gyroscope-sensor), or hand-held by a clinician (e.g., goniometer), to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness. Acquired data may be transferred to a computing device/software for recording/display and analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09413000123418	GS1