Sure PRO

Primary DI

05033435130825

Basic UDI-DI Code

5033435K00072ZP

Reference

K-SP

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

The Sure PRO is a versatile professional continence stimulator unit that offers the latest technology in a simple package that is equally suitable for home use. It has two independent stimulation channels and can be used with vaginal or anal electrodes, or for urge incontinence and pain with four self-adhesive electrode pads. The Sure PRO has 12 preset and 3 manual programmes. In addition to the standard settings, it has special programmes for transcutaneous stimulation of the tibial nerve for urge incontinence. The manual programmes can be adjusted by healthcare professionals to the specific needs of the patient.

Sure PRO 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. Sure PRO may help to relieve symptoms of chronic pelvic pain.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).