PeriCoach

Primary DI

09338067000598

Basic UDI-DI Code

93380670ALT202111001PL

Reference

PC0101

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Stratos MedTech Pty Ltd

The PeriCoach is a pelvic floor exercise aide, similar in application to a perineometer, which aims to treat incontinence and pelvic organ prolapse (POP)in women. It is often difficult for women to perform pelvic floor exercises and a) know what the muscles are doing, as well as b)measure any improvement. Strong pelvic floor muscles are the key to overcoming many forms of incontinence and prolapse and are always recommended as a first-line approach to improving the condition. Statistics show that 1 in 3 women worldwide suffer from incontinence. The PeriCoach system consists of the following components: - A Probe: a rigid probe that is temporarily inserted into the vagina. The probe measures the force applied by the pelvic floor muscles using surface mounted force sensing resistors (FSRs) and contains the necessary electronics to communicate this signal to a smartphone application. It is powered by are chargeable Lithium-Polymer(Li-Po) battery, and has recharging contacts at the base of the probe. - A Combination Carrier and Charger: a protective carry case which allows for the Probe to be recharged when it is placed in the Case and the Case is connected to a USB power source. - A USB Cable: used for connecting the Combination Carrier and Charger to appropriate power source(computer with spare USB port or a power adaptor). - Smartphone Application: GUI that displays the muscle activity to the patient, and offers pre-set exercise programs to follow, and ‘PeriTrack’, a bladder diary, as well as storing the data for transfer to the database. - Data hosting/management system: a secure database system that receives the exercise data and converts it into easy-to-read reports and graphs to be accessed by the user or her clinician (with permission) through an online Portal.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).