Danu

Basic Information

• Brand Name: Danu
• Primary DI: 05391550080006
• Version / Model: v1
• Company Name: DANU SPORTS LIMITED
• Labeler DUNS: 985691169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-17
• Public Version: 1
• Public Version Date: 2025-12-25
• Public Version Status: New
• Public Device Record Key: 1861efdc-86fa-43b4-b8fb-5c6bb2145aa0

Device Description

The Danu Smart Sock comprises a pair socks with a series of sensors integrated within the fabric for insole pressure measurement and inertial measurement data collection.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Lot/Batch Number: Yes
• 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
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	890.1600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36252	Kinesiology ambulatory recorder	A battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring.	No	Active
47518	Biomechanical function analysis/rehabilitation software	A software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing and/or enable viewing of patient performance data.	No	Active
61782	Pressure monitoring insole	A battery-powered device intended to be worn against the sole of the foot to sense, measure, and transmit information regarding plantar pressure distribution for the biomechanical analysis of gait. It is typically a synthetic insole with integrated pressure sensors and a wireless transmitter, whereby pressure distribution data is intended to be transmitted to, and analysed with, an off-the-shelf tablet/smartphone/computer containing dedicated software; a battery charger may be included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391550080006	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Xsmall
Device Size Text, specify			Small
Device Size Text, specify			Medium
Device Size Text, specify			Large
Device Size Text, specify			Xlarge
Device Size Text, specify			XXlarge