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/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/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 64) Showing 20 most recent of 64 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K240805](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K240805.md) | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. | Aug 1, 2024 | SESE | | [K231875](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K231875.md) | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | Feb 22, 2024 | SESE | | [K233362](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K233362.md) | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | Dec 29, 2023 | SESE | | [K231780](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K231780.md) | Perifit Care+ | X6 Innovations | Dec 20, 2023 | SESE | | [K221476](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K221476.md) | Perifit | X6 Innovations | Feb 10, 2023 | SESE | | [K213913](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K213913.md) | leva Pelvic Health System | Renovia, Inc. | Jun 30, 2022 | SESE | | [K212655](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K212655.md) | Flyte | Pelvital USA, Inc. | Sep 21, 2021 | SESE | | [K212495](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K212495.md) | Leva Pelvic Health System | Renovia, Inc. | Sep 8, 2021 | SESE | | [K210764](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K210764.md) | Flyte | Pelvital USA, Inc. | Apr 13, 2021 | SESE | | [K193364](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K193364.md) | Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose | Aug 24, 2020 | SESE | | [K200409](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K200409.md) | Pelvital System | Pelvital USA, Inc. | Jul 10, 2020 | SESE | | [K192270](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K192270.md) | LEva Pelvic Digital Health System | Renovia, Inc. | Nov 22, 2019 | SESE | | [K180637](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K180637.md) | leva Pelvic Floor Trainer | Renovia, Inc. | Apr 4, 2018 | SESE | | [K171896](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K171896.md) | Feminine Personal Trainer (FPT) | Ralston Group | Aug 29, 2017 | SESE | | [K162689](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K162689.md) | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | Jun 8, 2017 | SESE | | [K160758](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K160758.md) | PeriCoach OTC | Analytica, Ltd. | Jul 11, 2016 | SESE | | [K142355](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K142355.md) | Vaginal Tactile Imager | Advanced Tactile Imaging, Inc. | May 28, 2015 | SESE | | [K143580](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K143580.md) | PeriCoach | Analytica, Ltd. | Mar 18, 2015 | SESE | | [K141893](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K141893.md) | VIBRANCE KEGEL DEVICE (VKD) | Bioinfinity (M) Sdn. Bhd. | Dec 18, 2014 | SESE | | [K133990](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR/K133990.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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