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Medical Devices / Submissions and Approvals

FDA Clears Incontinence Device for Women

March 29, 2019
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The FDA granted InControl Medical 510(k) clearance for its OTC non-implantable muscle stimulator Attain, a device used to help women treat urinary or bowel incontinence.

The device delivers muscle stimulation through alternating, specific frequencies to provide neuromuscular retraining and increase pelvic floor muscle strength. The small, painless device can eliminate the need for pads or diapers.

Attain comes with a feedback graph and visual clues to help guide the user through timed contractions and a relaxation phase, similar to a physical therapy session.

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