← Product Code [HIR](/productcode/HIR) · K002043

# PELVEX HOMETRAINER (K002043)

_Purdue Technology Park · HIR · May 21, 2001 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K002043

## Device Facts

- **Applicant:** Purdue Technology Park
- **Product Code:** [HIR](/productcode/HIR.md)
- **Decision Date:** May 21, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1425
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/device/K002043](https://fda.innolitics.com/device/K002043)

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