Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1425](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1425) → HIR — Perineometer

# HIR · Perineometer

_Obstetrics/Gynecology · 21 CFR 884.1425 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/HIR

## Overview

- **Product Code:** HIR
- **Device Name:** Perineometer
- **Regulation:** [21 CFR 884.1425](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1425)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 65)

Showing 20 most recent of 65 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252748](/device/K252748.md) | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | Apr 27, 2026 | SESE |
| [K240805](/device/K240805.md) | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. | Aug 1, 2024 | SESE |
| [K231875](/device/K231875.md) | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | Feb 22, 2024 | SESE |
| [K233362](/device/K233362.md) | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | Dec 29, 2023 | SESE |
| [K231780](/device/K231780.md) | Perifit Care+ | X6 Innovations | Dec 20, 2023 | SESE |
| [K221476](/device/K221476.md) | Perifit | X6 Innovations | Feb 10, 2023 | SESE |
| [K213913](/device/K213913.md) | leva Pelvic Health System | Renovia, Inc. | Jun 30, 2022 | SESE |
| [K212655](/device/K212655.md) | Flyte | Pelvital USA, Inc. | Sep 21, 2021 | SESE |
| [K212495](/device/K212495.md) | Leva Pelvic Health System | Renovia, Inc. | Sep 8, 2021 | SESE |
| [K210764](/device/K210764.md) | Flyte | Pelvital USA, Inc. | Apr 13, 2021 | SESE |
| [K193364](/device/K193364.md) | Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose | Aug 24, 2020 | SESE |
| [K200409](/device/K200409.md) | Pelvital System | Pelvital USA, Inc. | Jul 10, 2020 | SESE |
| [K192270](/device/K192270.md) | LEva Pelvic Digital Health System | Renovia, Inc. | Nov 22, 2019 | SESE |
| [K180637](/device/K180637.md) | leva Pelvic Floor Trainer | Renovia, Inc. | Apr 4, 2018 | SESE |
| [K171896](/device/K171896.md) | Feminine Personal Trainer (FPT) | Ralston Group | Aug 29, 2017 | SESE |
| [K162689](/device/K162689.md) | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | Jun 8, 2017 | SESE |
| [K160758](/device/K160758.md) | PeriCoach OTC | Analytica, Ltd. | Jul 11, 2016 | SESE |
| [K142355](/device/K142355.md) | Vaginal Tactile Imager | Advanced Tactile Imaging, Inc. | May 28, 2015 | SESE |
| [K143580](/device/K143580.md) | PeriCoach | Analytica, Ltd. | Mar 18, 2015 | SESE |
| [K141893](/device/K141893.md) | VIBRANCE KEGEL DEVICE (VKD) | Bioinfinity (M) Sdn. Bhd. | Dec 18, 2014 | SESE |

## Top Applicants

- Pelvital USA, Inc. — 5 clearances
- Hollister, Inc. — 4 clearances
- Renovia, Inc. — 4 clearances
- Thought Technology , Ltd. — 3 clearances
- Verimed Holdings, Inc. — 3 clearances

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**Source:** [https://fda.innolitics.com/productcode/HIR](https://fda.innolitics.com/productcode/HIR)

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