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Physical therapy electrical stimulation system, battery-powered - ARTG 378810

Access comprehensive regulatory information for Physical therapy electrical stimulation system, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 378810 and sponsored by Compliance Management Solutions, manufactured by Shenzhen Kentro Medical Electronics Co Ltd in China. The device registration started on November 24, 2021.

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 IIa
ARTG 378810
Class IIa
Physical therapy electrical stimulation system, battery-powered
ARTG ID: 378810
Good Name: Compliance Management Solutions - Physical therapy electrical stimulation system, battery-powered
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Intended Purpose

The intended purpose of Fllow/Fllow Expert (KTR-405) is to provide relief of pain associated with sore or aching muscles on the foot due to strain from exercise or activities of daily living principally regular household and work activities. This product can promote the blood circulation of the feet and leg, reduce the pain and discomfort of the feet and legs, reduce swelling and cramps. The device comes with body electrodes that can temporarily relieve pain of neck, back, shoulder, arm, leg and hip.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
378810
Start Date
November 24, 2021
Effective Date
November 24, 2021
Manufacturer
Country
China
Address
2nd Floor No 11 Shanzhuang Road Xikeng Village Yuanshan Street Longgang District, Shenzhen City, Guangdon Province