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Orthosis, <specify>

Access comprehensive regulatory information for Orthosis, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Australian Physiotherapy Equipment, manufactured by Lenjoy Medical Engineering Inc in United States of America. The device registration started on January 05, 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
Class I
Orthosis, <specify>
Australia TGA ARTG Registered Device
Good Name: Australian Physiotherapy Equipment - Orthosis, <specify>
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Intended Purpose

A device designed to support, align, prevent or correct various joint movement dysfunctions caused by increased or decreased neuromuscular tone as a result of various neuromuscular disorders.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 05, 2023
Effective Date
January 05, 2023
Manufacturer
Country
United States of America
Address
13112 Crenshaw Boulevard, Gardena, CA, 90249