Australia flagARTG 428077

Patient data recorder, long-term, physical activity

ARTG ID: 428077 · Rehacare Pty Ltd · Linus Health Europe Ltd · Class I · Started November 17, 2023

Good Name: Rehacare Pty Ltd - Patient data recorder, long-term, physical activity

Device classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
428077
Start Date
November 17, 2023
Effective Date
November 17, 2023
Sponsor
Manufacturer
Country
Ireland
Address
NexusUCD Belfield Office Park, Clonskeagh, Dublin, D04 V2N9
Intended purpose

The device is intended to measure gait and mobility parameters for automated, quantitative gait and mobility assessment via a Timed Up and Go test, instrumented using body-worn inertial sensors. It's indicated for use with patients who would benefit from assessment of mobility. It is also indicated for patients who may benefit from assessment of fall risk or frailty.

About this record

Access comprehensive regulatory information for Patient data recorder, long-term, physical activity in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 428077 and sponsored by Rehacare Pty Ltd, manufactured by Linus Health Europe Ltd in Ireland. The device registration started on November 17, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

Free DatabasePowered by Pure Global AITGA ARTG Official Data