Product code HIR
- Device name
- Perineometer
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.1425
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-04-27 |
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. | 2024-08-01 |
| K231875 | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | 2024-02-22 |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | 2023-12-29 |
| K231780 | Perifit Care+ | X6 Innovations | 2023-12-20 |
| K221476 | Perifit | X6 Innovations | 2023-02-10 |
| K213913 | leva Pelvic Health System | Renovia, Inc. | 2022-06-30 |
| K212655 | Flyte | Pelvital USA, Inc. | 2021-09-21 |
| K212495 | Leva Pelvic Health System | Renovia, Inc. | 2021-09-08 |
| K210764 | Flyte | Pelvital USA, Inc. | 2021-04-13 |
| K193364 | Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose | 2020-08-24 |
| K200409 | Pelvital System | Pelvital USA, Inc. | 2020-07-10 |
| K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | 2019-11-22 |
| K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | 2018-04-04 |
| K171896 | Feminine Personal Trainer (FPT) | Ralston Group | 2017-08-29 |
| K162689 | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | 2017-06-08 |
| K160758 | PeriCoach OTC | Analytica, Ltd. | 2016-07-11 |
| K142355 | Vaginal Tactile Imager | Advanced Tactile Imaging, Inc. | 2015-05-28 |
| K143580 | PeriCoach | Analytica, Ltd. | 2015-03-18 |
| K141893 | VIBRANCE KEGEL DEVICE (VKD) | Bioinfinity (M) Sdn. Bhd. | 2014-12-18 |
| K133990 | IEVA REHABILITATIVE POSITIONAL DEVICE | Remendium Labs, LLC | 2014-10-09 |
| K140780 | KEGEL SMART, KEGELSMART PEARL | Regulatory Insight, Inc. | 2014-09-10 |
| K122800 | INNER PEACE | Kamabry, Inc., Dba Inner Peace For Women | 2013-10-04 |
| K121902 | NATRATONE | Orelle Corporation, Ltd. | 2013-06-06 |
| K082436 | EXTT-101 | Apimeds, Inc. | 2009-05-29 |
| K023305 | KEGELMASTER 2000 | Kegelmaster 2000 , Ltd. | 2002-12-26 |
| K021115 | GYNEFLEX | Naissance Holdings, LC | 2002-12-20 |
| K011688 | PELVICFLEXER EXERCISE DEVICE | Pelvicflex, Inc. | 2002-03-20 |
| K013612 | INCARE PELVIC FLOOR THERAPY SYSTEM | Hollister, Inc. | 2002-03-19 |
| K013653 | INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE | Hollister, Inc. | 2002-03-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00864124000137 | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | 2026-04-23 |
| 04719872333616 | Levina | ZMI ELECTRONICS LTD. | 2026-04-14 |
| 04719872333593 | Levina | ZMI ELECTRONICS LTD. | 2026-04-14 |
| 04719872333104 | Levina | ZMI ELECTRONICS LTD. | 2026-04-14 |
| 04719871184837 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2023-08-25 |
| 04719871184820 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2023-08-25 |
| 04719871184813 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2023-08-25 |
| 04719871184806 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2023-08-25 |
| 04719871184790 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2023-08-25 |
| 04719871184783 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2023-08-25 |
| 04719871184776 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2023-08-25 |
| 04719871184769 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2023-08-25 |
| 04719871184844 | Everyway | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2022-03-17 |
| 04719871183977 | Everyway | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2022-03-17 |
| 04719871183960 | Everyway | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2022-03-17 |
| 09555860800006 | Vibrance® Pelvic Trainer | BIOINFINITY (M) SDN. BHD. | 2017-07-31 |
| 04719871183410 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2016-12-02 |
| 04719871183403 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2016-12-02 |
| 04719871183397 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2016-12-02 |
| 04719871183380 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2016-12-02 |
| 04719871183373 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2016-12-02 |
| 04719871183106 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2016-12-02 |
| 04719871183083 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2016-12-02 |
| 04719871183069 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2016-12-02 |
| 04719871183045 | Lifecare | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | 2016-12-02 |
| 08519520070009 | IVS-2 | PERSONAL MEDICAL CORP. | 2016-10-18 |
| 08519520070003 | SenseRx -- Anal/Small Vaginal and Vaginal EMG | PERSONAL MEDICAL CORP. | 2016-10-04 |
| 10627825006290 | Peritron | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 10627825006283 | Peritron | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 10627825006276 | Peritron | Laborie Medical Technologies Canada ULC | 2016-09-21 |