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Patient data recorder, long-term, physical activity - ARTG 428077

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.

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TGA ARTG Official Data
Class I
ARTG 428077
Class I
Patient data recorder, long-term, physical activity
ARTG ID: 428077
Good Name: Rehacare Pty Ltd - Patient data recorder, long-term, physical activity
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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.

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