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Deep-tissue electromagnetic stimulation system, professional - ARTG 387555

Access comprehensive regulatory information for Deep-tissue electromagnetic stimulation system, professional in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 387555 and sponsored by Jonathan Kew Private Assists, manufactured by Deleo S.A.S in France. The device registration started on April 27, 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.

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Class IIa
ARTG 387555
Class IIa
Deep-tissue electromagnetic stimulation system, professional
ARTG ID: 387555
Good Name: Jonathan Kew Private Assists - Deep-tissue electromagnetic stimulation system, professional
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Intended Purpose

(1) Rehabilitation of the pelvic floor muscles in the treatment of urinary incontinence. During high-energy treatment with this system, strong electromagnetic pulses are generated to contract the pelvic floor muscles, which are weakened in urinary incontinence. Powerful electromagnetic pulses will generate stimulation of the muscles, causing them to contract. As a result, the pelvic floor muscles will be strengthened and help improve urinary continence.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
387555
Start Date
April 27, 2022
Effective Date
April 27, 2022
Manufacturer
Country
France
Address
239 via Nova, Pole d'Excellence Jean Louis, Frejus, 83600