Which Kegel Trainers Are FDA-Cleared?

The short answer

Of the kegel trainers we compared, these have FDA 510(k) clearance: Perifit Care, Perifit Care+, Elitone, Elitone for Men and Yarlap, plus Leva for prescription use. We found no clearance for the Elvie Trainer, kGoal, Emy, Intimina KegelSmart 2 or the Kegel8 models sold today. We searched the FDA's 510(k), registration and classification data (last updated October 26, 2026) and read the 510(k) summaries.

Every clearance we found

The Perifit clearance K221476 is filed under the name "Perifit"; Perifit says both Care and Care+ are cleared.

No clearance found

• Elvie Trainer: no 510(k) found. Elvie's clearances are for breast pumps, and its instructions call the Trainer an exercise device.
• kGoal Classic and Boost: no 510(k) or listing found. kGoal says its products are general fitness and wellness trackers rather than medical devices.
• Emy (Fizimed): no 510(k) found. Its US page calls it a "CE marked medical device", which is a European mark, not FDA clearance.
• Intimina KegelSmart 2: no 510(k) names it. A "KegelSmart 2 Plus" is registered with the FDA under a contract manufacturer, but registration is not clearance, and Intimina makes no FDA claim for it.
• Kegel8 Ultra 20 V2 and V for Men: the only Kegel8 clearance, K081480 from 2008, is for an older prescription model. Kegel8 markets the Ultra 20 V2 as a CE-certified medical device.

Cleared, approved or registered?

• Cleared means the FDA accepted a 510(k): the maker showed the device is substantially equivalent to one already legally sold. The FDA classes perineometers (pressure trainers) and non-implanted electrical continence stimulators as Class II devices that need a 510(k). Clearance is for a specific use, usually urinary incontinence.
• Approved refers to the stricter premarket approval route for higher-risk devices. Kegel trainers are cleared, not approved, so "FDA-approved kegel trainer" is usually loose wording.
• Registered or listed only means a company has told the FDA it makes or sells a device. It is not a review of safety or effectiveness.
• CE marked is the European conformity mark. It says nothing about FDA status.

Clearance does not mean a device works better than doing kegels on your own. For that, see do kegel trainers work?

FDA-cleared trainers you can buy without a prescription

Prices from each maker's US store.

Frequently asked questions

Is Perifit FDA-approved?

Perifit is FDA-cleared, which is the usual route for this kind of device: K221476 (February 2023) and, for Care+, K231780 (December 2023), both for over-the-counter use for stress, mild-to-moderate urge and mixed incontinence in adult women.

Is the Elvie Trainer FDA-cleared?

We found no 510(k) for an Elvie trainer. Elvie's FDA clearances are for breast pumps.

Is Elitone FDA-cleared?

Yes. Elitone has K183585 (2019) for stress incontinence in women, Elitone URGE has K223884 (2023) for urge incontinence, and Elitone for Men has K253285 (January 2026) for early continence recovery after prostate surgery.

Is kGoal FDA-approved?

No. kGoal says its trainers are general fitness and wellness trackers rather than medical devices, and we found no FDA clearance or listing.

What is the difference between FDA-cleared and FDA-approved?

Clearance (510(k)) means a device is substantially equivalent to one already legally sold. Approval is a stricter route for higher-risk devices. Kegel trainers are cleared, not approved.

Not sure which trainer fits you?

Our main comparison lines up every device by how it gives feedback, whether it needs an app, its FDA status and its price.

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