Australia TGA ARTG record

Physical therapy electrical stimulation system, battery-powered

Australia TGA ARTG Registered Device · Compliance Management Solutions · Shenzhen Kentro Medical Electronics Co Ltd · Class IIa · Started October 11, 2022

Good Name: Compliance Management Solutions - Physical therapy electrical stimulation system, battery-powered

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 11, 2022
Effective Date: October 11, 2022

Sponsor

Name: Compliance Management Solutions

Manufacturer

Name: Shenzhen Kentro Medical Electronics Co Ltd
Country: China
Address: No 11 Shanzhuang Road Xikeng Village Yuanshan Street Longgang District, Shenzhen City, Guangdon Province

Intended purpose

Fllow Lite (KTR-405 Fllow Lite) is a medical device designed to be used in the home for users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet. Neuromuscular Electrical Stimulation (NMES) though the footpads encourage your calf muscles to contract. This movement temporarily improves local blood flow. Fllow Lite may: 1. Increase the blood circulation in the feet and lower legs* 2. Relieve pain associated with sore or aching muscles on the feet and legs due to strain from exercise and regular household and work activities* 3. Reduce pain or discomfort linked to poor circulation, reduce swelling and feelings of tiredness and heaviness of the feet and legs* 4. Improve mobility through regular product use* 5. Fllow Lite can be safely used by those with diabetes (*Fllow Lite is not intended to replace exercise or your current medication programme and its benefits are temporary) The TENS body pads (SOLD SEPARATELY) are used to: - Relieve pain associated with sore and aching muscles and joints in the neck, back, shoulder, arm, leg, and hip. - Stimulating pulses provide temporary targeted pain relief. The Arthro-Fllow pads (SOLD SEPARATELY) are used to: - Strengthen muscles that help support the knee and relieve knee joint pain associated with arthritis of the knee.

About this record

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 sponsored by Compliance Management Solutions, manufactured by Shenzhen Kentro Medical Electronics Co Ltd in China. The device registration started on October 11, 2022.

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.