Pure Global

Orthosis, leg, ankle/foot, unit

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 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
Class I
Orthosis, leg, ankle/foot, unit
Australia TGA ARTG Registered Device
Good Name: Darren Pereira - Orthosis, leg, ankle/foot, unit
Pure Global
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Intended Purpose

The PIVOT ankle joint is the lowest profile thermoplastic orthotic ankle joint available and its design offers free ankle motion in an elegant and streamlined solution for custom articulated Ankle Foot Orthoses (AFO). Attention to detail has simplified the fabrication process and reduced lateral projection by adding the thread height after the fabrication. Assembly is simple and fast with indexed bushings that don't spin during installation.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
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