Kegelbell, a "Pelvic Floor Muscle Training Device" to Support Prevention and Improvement of Urinary Incontinence, Finally Launched in Japan

■ About the change in circumstances

Until now, devices used for pelvic floor muscle exercises by insertion into the vagina, such as "Kegelbell," were sold in Japan as "miscellaneous goods," and it was legally impossible to claim their effects and efficacy. For example, despite their actual function of "training to improve" urinary incontinence (stress urinary incontinence) caused by weakened pelvic floor muscles due to childbirth, aging, or desk work, the attributes of these products were not registered with the Ministry of Health, Labour and Welfare, making it impossible to communicate their benefits to consumers.

In Japan, the Pharmaceuticals and Medical Devices Act (hereinafter referred to as the PMD Act), which has one of the strictest standards in the world for ensuring the quality, efficacy, and safety of pharmaceuticals and medical devices, has been enacted to protect consumer safety. On the other hand, for "Femtech" products, there has been no similar product distributed in Japanese society until now, and there is a reality that there is no means to properly claim their effects and efficacy. Since its establishment, fermata has been discussing with various stakeholders, including the Ministry of Health, Labour and Welfare, to create a foundation for properly distributing Femtech products, which embody new values, to the market and protecting consumers. As a result, "pelvic floor muscle training device" was newly established as a general medical device name in 2022.

■ About Kegelbell, a pelvic floor muscle training device

This item allows you to perform Kegel exercises = pelvic floor muscle training, with the aim of improving urinary incontinence (stress urinary incontinence) that occurs when you run, jump, cough, or sneeze due to weakened pelvic floor muscles caused by childbirth, aging, or desk work. The founder, Stephanie, developed this training as a necessary and easy-to-continue exercise for "modern women to live comfortably at any age," after realizing that many women do not have sufficiently developed pelvic floor muscles, and that they choose dangerous and incorrect solutions when trying to improve their symptoms, which was triggered by her mother suffering chronic symptoms from pelvic floor muscle surgery.

This item will be relaunched*2 now that pelvic floor muscle training items have been approved as medical devices in Japan under the name "pelvic floor muscle training device."

*2 This is not a renewal of product specifications.

[How to use]

① Before use, wash your hands thoroughly, and wash the main parts with soap and lukewarm water, then rinse well.
② Lay a clean towel between your legs. Open your legs and stand with your knees slightly bent.
③ First, try with only the small main part. Insert the insertion part of the main part, keeping the cord outside.
④ Test if you can keep the inserted main part in place while standing.
⑤ If you cannot keep the small main part in the vagina, switch to the large main part and try again.
⑥ If you cannot keep it in place even with the large main part, train while lying down. If you can keep it in place while standing, gradually increase the weight while standing.

The weight can be adjusted to 8 levels from 30g to 240g*3 depending on the condition of your pelvic floor muscles.

*3 Two sizes of parts are included for vaginal insertion, this applies when using the small part.

[Product Overview]

Product name: Kegelbell Pelvic Floor Trainer KE

Price: 15,400 yen (tax included)

Medical device notification number: 13B2X10428005001

Product URL: https://hellofermata.com/products/kegelbell

The press release URL is here. For inquiries regarding this matter, please contact fermata Public Relations at info@hellofermata.com.