HIR · Perineometer
Obstetrics/Gynecology · 21 CFR 884.1425 · Class 2
Overview
| Product Code | HIR |
|---|---|
| Device Name | Perineometer |
| Regulation | 21 CFR 884.1425 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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 64)
Showing 20 most recent of 64 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. | Aug 1, 2024 | SESE |
| K231875 | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | Feb 22, 2024 | SESE |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | Dec 29, 2023 | SESE |
| K231780 | Perifit Care+ | X6 Innovations | Dec 20, 2023 | SESE |
| K221476 | Perifit | X6 Innovations | Feb 10, 2023 | SESE |
| K213913 | leva Pelvic Health System | Renovia, Inc. | Jun 30, 2022 | SESE |
| K212655 | Flyte | Pelvital USA, Inc. | Sep 21, 2021 | SESE |
| K212495 | Leva Pelvic Health System | Renovia, Inc. | Sep 8, 2021 | SESE |
| K210764 | Flyte | Pelvital USA, Inc. | Apr 13, 2021 | SESE |
| K193364 | Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose | Aug 24, 2020 | SESE |
| K200409 | Pelvital System | Pelvital USA, Inc. | Jul 10, 2020 | SESE |
| K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | Nov 22, 2019 | SESE |
| K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | Apr 4, 2018 | SESE |
| K171896 | Feminine Personal Trainer (FPT) | Ralston Group | Aug 29, 2017 | SESE |
| K162689 | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | Jun 8, 2017 | SESE |
| K160758 | PeriCoach OTC | Analytica, Ltd. | Jul 11, 2016 | SESE |
| K142355 | Vaginal Tactile Imager | Advanced Tactile Imaging, Inc. | May 28, 2015 | SESE |
| K143580 | PeriCoach | Analytica, Ltd. | Mar 18, 2015 | SESE |
| K141893 | VIBRANCE KEGEL DEVICE (VKD) | Bioinfinity (M) Sdn. Bhd. | Dec 18, 2014 | SESE |
| K133990 | IEVA REHABILITATIVE POSITIONAL DEVICE | Remendium Labs, LLC | Oct 9, 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
