9b04cb5f-a345-406c-884a-f8a1caaf8279NewPublished12021-08-122021-08-04In Commercial Distribution00860331002018PrimaryGS1Flyte In-Home Pelvic Floor TreatmentMTI-1080346522PELVITAL USA, INC.1falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsetrueK20040900032686PerineometerA device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The device measures the strength of the perineal muscles by offering resistance to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, urinary incontinence or sexual dysfunction.falseActiveHIRPerineometerfalsefalse