Perineometer
FDA product code HIR · Class II (moderate risk) · 21 CFR 884.1425 · Obstetrics/Gynecology
65510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Pelvital USA, Inc. 5
- Renovia, Inc. 4
- Hollister, Inc. 4
- Verimed Holdings, Inc. 3
- Thought Technology , Ltd. 3
- Bioinfinity (M) Sdn. Bhd. 2
- Analytica, Ltd. 2
- X6 Innovations 2
- The Prometheus Group 2
- Cardio Design Pty. , Ltd. 2
- Deschutes Medical Products, Inc. 2
- Empi 2
- Advanced Tactile Imaging, Inc. 2
- Peritone Research, Ltd. 2
- Laurie Ann Kaiser, Ph.D. 2
- Sandhill Scientific, Inc. 1
- Laborie Medical Technologies, Ltd. 1
- Hunan Accurate Bio-Medical Technology Co., Ltd. 1
- Bivona Medical Technologies 1
- Milex Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252748 | Pelvic Floor Exerciser (PF01)HIR · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 04/27/2026SE |
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)HIR · Traditional | Pelvital USA, Inc. | 08/01/2024SE |
| K231875 | Vaginal Tactile Ultrasound ImagerHIR · Traditional | Advanced Tactile Imaging, Inc. | 02/22/2024SE |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)HIR · Special | Pelvital USA, Inc. | 12/29/2023SE |
| K231780 | Perifit Care+HIR · Traditional | X6 Innovations | 12/20/2023SE |
| K221476 | PerifitHIR · Traditional | X6 Innovations | 02/10/2023SE |
| K213913 | leva Pelvic Health SystemHIR · Traditional | Renovia, Inc. | 06/30/2022SE |
| K212655 | FlyteHIR · Special | Pelvital USA, Inc. | 09/21/2021SE |
| K212495 | Leva Pelvic Health SystemHIR · Special | Renovia, Inc. | 09/08/2021SE |
| K210764 | FlyteHIR · Special | Pelvital USA, Inc. | 04/13/2021SE |
| K193364 | Intimate Rose Kegel Exercise SystemHIR · Traditional | Plus EV Holdings Dba Intimate Rose | 08/24/2020SE |
| K200409 | Pelvital SystemHIR · Traditional | Pelvital USA, Inc. | 07/10/2020SE |
| K192270 | LEva Pelvic Digital Health SystemHIR · Traditional | Renovia, Inc. | 11/22/2019SE |
| K180637 | leva Pelvic Floor TrainerHIR · Traditional | Renovia, Inc. | 04/04/2018SE |
| K171896 | Feminine Personal Trainer (FPT)HIR · Traditional | Ralston Group | 08/29/2017SE |
| K162689 | Vibrance Pelvic TrainerHIR · Traditional | Bioinfinity (M) Sdn. Bhd. | 06/08/2017SE |
| K160758 | PeriCoach OTCHIR · Traditional | Analytica, Ltd. | 07/11/2016SE |
| K142355 | Vaginal Tactile ImagerHIR · Traditional | Advanced Tactile Imaging, Inc. | 05/28/2015SE |
| K143580 | PeriCoachHIR · Traditional | Analytica, Ltd. | 03/18/2015SE |
| K141893 | Vibrance Kegel Device (VKD)HIR · Traditional | Bioinfinity (M) Sdn. Bhd. | 12/18/2014SE |
| K133990 | Ieva Rehabilitative Positional DeviceHIR · Traditional | Remendium Labs, LLC | 10/09/2014SE |
| K140780 | Kegel Smart, Kegelsmart PearlHIR · Traditional | Regulatory Insight, Inc. | 09/10/2014SE |
| K122800 | Inner PeaceHIR · Traditional | Kamabry, Inc., Dba Inner Peace For Women | 10/04/2013SE |
| K121902 | NatratoneHIR · Traditional | Orelle Corporation, Ltd. | 06/06/2013SE |
| K082436 | EXTT-101HIR · Traditional | Apimeds, Inc. | 05/29/2009SE |
| K023305 | Kegelmaster 2000HIR · Traditional | Kegelmaster 2000 , Ltd. | 12/26/2002SE |
| K021115 | GyneflexHIR · Traditional | Naissance Holdings, LC | 12/20/2002SE |
| K011688 | Pelvicflexer Exercise DeviceHIR · Traditional | Pelvicflex, Inc. | 03/20/2002SE |
| K013612 | Incare Pelvic Floor Therapy SystemHIR · Traditional | Hollister, Inc. | 03/19/2002SE |
| K013653 | Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure ProbeHIR · Traditional | Hollister, Inc. | 03/05/2002SE |
| K002043 | Pelvex HometrainerHIR · Traditional | Purdue Technology Park | 05/21/2001SE |
| K002617 | Periform Perineometric Probe, Model 8300HIR · Traditional | Neen Design , Ltd. | 04/05/2001SE |
| K002830 | Pelvic Muscle TherapyHIR · Traditional | Colonial Medical Supply | 12/27/2000SE |
| K002834 | SRS Vaginal Emg/Stimulation Perineometer Sensor SRS Anal Emg/Stimulation Perineometer…HIR · Traditional | Srs Medical Systems, Inc. | 11/29/2000SE |
| K994079 | Reflex Treatment SystemHIR · Traditional | Deschutes Medical Products, Inc. | 03/01/2000SE |
| K993411 | Femiscan Clinic System, Model Fs-Ictra and Femiscan Personal System, Model Fs-HmtrHIR · Traditional | Mega Electronics , Ltd. | 01/10/2000SE |
| K981277 | PeriformHIR · Traditional | Verimed Holdings, Inc. | 11/20/1998SE |
| K983052 | Peritron Perineometer Model 9300V or 9300AHIR · Traditional | Cardio Design Pty. , Ltd. | 10/19/1998SE |
| K974036 | Pathway Vaginal/Rectal Perineometer ProbeHIR · Traditional | The Prometheus Group | 12/22/1997SE |
| K970145 | Perineometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe)HIR · Traditional | Biosearch Medical Products, Inc. | 08/11/1997SE |
| K960508 | Pathway Electromyograph Model Pathway II/MR-10/MR-15/MR-20/MR-25HIR · Traditional | The Prometheus Group | 01/16/1997SE |
| K960311 | PerineometerHIR · Traditional | Hollister, Inc. | 04/18/1996SE |
| K945611 | PeritronHIR · Traditional | Cardio Design Pty. , Ltd. | 02/08/1996SE |
| K952688 | Innova Rectal or Small Vaginal Emg Sensing ElectrodeHIR · Traditional | Empi | 12/06/1995SE |
| K925681 | MYOTRAC2D/CSHIR · Traditional | Thought Technology , Ltd. | 09/29/1995SE |
| K934552 | PeripumpHIR · Traditional | Deschutes Medical Products, Inc. | 08/09/1995SE |
| K945937 | TE-800 Pelvic Floor ExerciserHIR · Traditional | Myo/Kinetic Systems, Inc. | 07/14/1995SE |
| K942563 | Elite BiofeedbackHIR · Traditional | Laborie Medical Technologies, Ltd. | 06/06/1995SE |
| K935213 | IncontrolHIR · Traditional | Thought Technology , Ltd. | 05/11/1995SE |
| K932149 | Thought Technology Vaginal & Rectal ElectrodeHIR · Traditional | Thought Technology , Ltd. | 05/11/1995SE |
| K940091 | Innova Vaginal Emg Sensing ElectrodeHIR · Traditional | Empi | 12/29/1994SE |
| K926218 | Eisman-Tries Mep (Multiple Electrode Probe)HIR · Traditional | Sandhill Scientific, Inc. | 08/26/1994SE |
| K913912 | Verimed PerineometerHIR · Traditional | Verimed Holdings, Inc. | 06/16/1992SE |
| K911190 | Perrymeter(Tm)HIR · Traditional | Perrymeter Systems | 07/26/1991SE |
| K892888 | Extaciser Perineal Muscle ExerciserHIR · Traditional | Bivona Medical Technologies | 10/05/1989SE |
| K891774 | Contimed II Biofeedback Dev Treat of Urin IncontiHIR · Traditional | Hollister, Inc. | 08/23/1989SE |
| K862410 | Milex Kegel Perineal ExerciserHIR · Traditional | Milex Products, Inc. | 07/31/1986SE |
| K861858 | Vaginal Chamber Pellethane-Medical Grade 2363HIR · Traditional | Peritone Research, Ltd. | 07/31/1986SE |
| K854193 | Electro-Myographic PerineometerHIR · Traditional | Verimed Holdings, Inc. | 06/09/1986SE |
| K861683 | Monsanto Santoprene (Peritone Device)HIR · Traditional | Peritone Research, Ltd. | 06/02/1986SE |
| K860552 | Peritone Disposal Sheath - Rubber and VinylHIR · Traditional | Laurie Ann Kaiser, Ph.D. | 04/17/1986SE |
| K821664 | PP-100, Personal PerineometerHIR · Traditional | Farrall Instruments, Inc. | 07/13/1982SE |
| K800191 | PeritoneHIR · Traditional | Laurie Ann Kaiser, Ph.D. | 04/16/1980SE |
| K800303 | Electronic PerineometerHIR · Traditional | Associates IN Biofeedback | 03/03/1980SE |
| K782083 | VagatexHIR · Traditional | Vagatex | 01/03/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2087-2019 Class II | Maximum Pelvic Trainer (MPT)The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if… | Ralston Group | 07/12/2019Terminated |