PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
Device Facts
| Record ID | K960508 |
|---|---|
| Device Name | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 |
| Applicant | The Prometheus Group |
| Product Code | HIR · Obstetrics/Gynecology |
| Decision Date | Jan 16, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1425 |
| Device Class | Class 2 |
Regulatory Classification
Identification
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.
