Eu Mdr Eu Md Class 2a On The Market

PELVIC FLOOR REHABILITATION DEVICES - OTHER

iTouch sure is a medical device designed to be used in the home healthcare environment to treat symptoms of urinary and/or faecal incontinence and is suitable for use by all who can control the device and understand the instructions. Do not use the device for any purpose other than this intended use.

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
05033435132362
Basic UDI-DI Code
5033435K00025ZE
Reference
K-ITS-GO
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

The itouch sure is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal probe with stainless steel electrodes. These signals make your pelvic floor muscles contract. If you have forgotten how to contract them, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the itouch sure can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. The itouch sure is very easy to use, with four clearly labelled preset training programmes and a simple push button control.

Medical Purpose

iTouch sure is a medical device designed to be used in the home healthcare environment to treat symptoms of urinary and/or faecal incontinence and is suitable for use by all who can control the device and understand the instructions. Do not use the device for any purpose other than this intended use.

CND Nomenclature Codes

Code Description
U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER

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