EmbaGYN

TENSCARE LIMITED · Model itouch Sure · UDI-DI 05033435132171

KPI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

EmbaGYN Pelvic Floor Exerciser is a portable, battery operated electrical muscle stimulator. EmbaGYN is indicated for the rehabilitation and strengthening of weak pelvic floor muscles in the treatment of stress, urge, and mixed urinary incontinence. It is designed to be extremely easy to use, and is intended for daily use by the patient in their own home. The EmbaGYN is supplied with a Liberty vaginal electrode that may not be sterilised and is intended for single patient use.

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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.