TensCare

TENSCARE LIMITED · Model iTouch Sure · UDI-DI 05033435070039

510(k) clearances

Adverse events

Recalls

Facilities

Description

The iTouch Sure 2 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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.