INTIMINA

Primary DI

07350075029226

Basic UDI-DI Code

7350075029875XY

Reference

2

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Suzhou Armocon Technology Co., Ltd.

lntimina KegelSmart 2 is a pelvic floor exercise device that provides biofeedback and exercise guidance. The device consists of a vaginal probe only (KegelSmart 2 bullet shaped, KegelSmart 2 Pearl egg shaped), with a medical-grade silicone applied part with a retraction cord at one end. The design is waterproof (submerged up to l m) so can be thoroughly washed. It functions through an electric resistance strain gauge to measure pressure, a simple microprocessor and a motor to emit vibrations. KegelSmart 2 will be powered by a 3.7V 200mAh Li-battery

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