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Orthosis, leg, ankle/foot, unit - ARTG 301875

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 301875 and sponsored by Darren Pereira, manufactured by LaunchPad O&P in United States of America. The device registration started on April 14, 2018.

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 301875
Class I
Orthosis, leg, ankle/foot, unit
ARTG ID: 301875
Good Name: Darren Pereira - Orthosis, leg, ankle/foot, unit
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Intended Purpose

X-TENSION is a post-fabrication component designed to resist or stop tibial progression in the sagittal plane to restore confidence throughout stance phase, resulting in increased third rocker power, contralateral step length, and single limb stance stability. It can also be used to ease transitioning the AFO. By choosing the appropriate bumper height, X-TENSION can be added to an articulated AFO to rigidly lock the orthosis, simulating a solid ankle design.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
301875
Start Date
April 14, 2018
Effective Date
April 14, 2018
Sponsor
Manufacturer
Country
United States of America
Address
2545 Chicargo Avenue Suite 507, Minneapolis, MN, 55404