Intimina KegelSmart - ML2(EN/IT/SV/FI)
Leloi AB · Model 0035 · UDI-DI 07350075020032
10
510(k) clearances
2
Adverse events
1
Recalls
27
Facilities
Description
A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-07-12 | Ralston Group | The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the de |
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Get your free API keyRead the docsData 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.