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Orthosis, leg, ankle/foot, unit - ARTG 443411

Access comprehensive regulatory information for Orthosis, leg, ankle/foot, unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 443411 and sponsored by Motion is Life Pty Ltd, manufactured by Span Link International LLC in United States of America. The device registration started on March 08, 2024.

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 443411
Class I
Orthosis, leg, ankle/foot, unit
ARTG ID: 443411
Good Name: Motion is Life Pty Ltd - Orthosis, leg, ankle/foot, unit
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Intended Purpose

The b:joynz ankle brace is a medical device. It is an ankle orthosis for stabilization with limitation of pronation and supination.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
443411
Start Date
March 08, 2024
Effective Date
March 08, 2024
Manufacturer
Country
United States of America
Address
28 West Jefryn Boulevard Suite C, Deer Park, New York, 11729