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Pelvic floor exercise biofeedback device - ARTG 424350

Access comprehensive regulatory information for Pelvic floor exercise biofeedback device in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 424350 and sponsored by ACRA Regulatory Services Pty Ltd, manufactured by Shenzhen XFT Medical Limited in China. The device registration started on October 06, 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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Class I
ARTG 424350
Class I
Pelvic floor exercise biofeedback device
ARTG ID: 424350
Good Name: ACRA Regulatory Services Pty Ltd - Pelvic floor exercise biofeedback device
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Intended Purpose

The device is a wireless kegel exerciser intended to increase precision, motivation and regularity of your pelvic floor workouts. The device is composed of a device and an app that form an interactive platform that will guide you through Kegel exercises. It is intended for: encouraging regular pelvic floor exercises; strengthening of the pelvic floor muscles; rehabilitation and training of weak pelvic floor muscle; treatment of stress, urge and mixed urinary incontinence in women; improving sexual pleasure or function in women with existing pelvic floor dysfunction; improving pelvic floor function in the post-partum period, including improving strength, reducing dysfunction, reducing urinary incontinence and improving sexual function; improving mild to moderate prolapse symptoms

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
424350
Start Date
October 06, 2023
Effective Date
October 06, 2023
Manufacturer
Country
China
Address
Room 203 Building 1 Biomedicine Innovations Industrial Park #14 Jinhui Road, Pingshan New District, Shenzhen, 518122