Panels › Obstetrics/Gynecology › Product code HIR · Class 2
Perineometer
Regulation 884.1425
1510(k)s in 12 months (65 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HIR
| Company | 510(k)s | Recalls |
|---|---|---|
| Pelvital USA, Inc. | 5 | 0 |
| Hollister, Inc. | 4 | 0 |
| Renovia, Inc. | 4 | 0 |
| Thought Technology , Ltd. | 3 | 0 |
| Verimed Holdings, Inc. | 3 | 0 |
| Advanced Tactile Imaging, Inc. | 2 | 0 |
| Analytica, Ltd. | 2 | 0 |
| Bioinfinity (M) Sdn. Bhd. | 2 | 0 |
| Cardio Design Pty. , Ltd. | 2 | 0 |
| Deschutes Medical Products, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 2026 | K252748 | Pelvic Floor Exerciser (PF01) Hunan Accurate Bio-Medical Technology Co., Ltd., CN | HIR |
| Aug 1, 2024 | K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) Pelvital USA, Inc. | HIR |
| Feb 22, 2024 | K231875 | Vaginal Tactile Ultrasound Imager Advanced Tactile Imaging, Inc. | HIR |
| Dec 29, 2023 | K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) Pelvital USA, Inc. | HIR |
| Dec 20, 2023 | K231780 | Perifit Care+ X6 Innovations, FR | HIR |
| Feb 10, 2023 | K221476 | Perifit X6 Innovations, FR | HIR |
| Jun 30, 2022 | K213913 | leva Pelvic Health System Renovia, Inc. | HIR |
| Sep 21, 2021 | K212655 | Flyte Pelvital USA, Inc. | HIR |
| Sep 8, 2021 | K212495 | Leva Pelvic Health System Renovia, Inc. | HIR |
| Apr 13, 2021 | K210764 | Flyte Pelvital USA, Inc. | HIR |
| Aug 24, 2020 | K193364 | Intimate Rose Kegel Exercise System Plus EV Holdings Dba Intimate Rose | HIR |
| Jul 10, 2020 | K200409 | Pelvital System Pelvital USA, Inc. | HIR |
| Nov 22, 2019 | K192270 | LEva Pelvic Digital Health System Renovia, Inc. | HIR |
| Apr 4, 2018 | K180637 | leva Pelvic Floor Trainer Renovia, Inc. | HIR |
| Aug 29, 2017 | K171896 | Feminine Personal Trainer (FPT) Ralston Group | HIR |
| Jun 8, 2017 | K162689 | Vibrance Pelvic Trainer Bioinfinity (M) Sdn. Bhd., MY | HIR |
| Jul 11, 2016 | K160758 | PeriCoach OTC Analytica, Ltd., AU | HIR |
| May 28, 2015 | K142355 | Vaginal Tactile Imager Advanced Tactile Imaging, Inc. | HIR |
| Mar 18, 2015 | K143580 | PeriCoach Analytica, Ltd., AU | HIR |
| Dec 18, 2014 | K141893 | VIBRANCE KEGEL DEVICE (VKD) Bioinfinity (M) Sdn. Bhd. | HIR |
| Oct 9, 2014 | K133990 | IEVA REHABILITATIVE POSITIONAL DEVICE Remendium Labs, LLC | HIR |
| Sep 10, 2014 | K140780 | KEGEL SMART, KEGELSMART PEARL Regulatory Insight, Inc. | HIR |
| Oct 4, 2013 | K122800 | INNER PEACE Kamabry, Inc., Dba Inner Peace For Women | HIR |
| Jun 6, 2013 | K121902 | NATRATONE Orelle Corporation, Ltd. | HIR |
| May 29, 2009 | K082436 | EXTT-101 Apimeds, Inc. | HIR |
| Dec 26, 2002 | K023305 | KEGELMASTER 2000 Kegelmaster 2000 , Ltd. | HIR |
| Dec 20, 2002 | K021115 | GYNEFLEX Naissance Holdings, LC | HIR |
| Mar 20, 2002 | K011688 | PELVICFLEXER EXERCISE DEVICE Pelvicflex, Inc. | HIR |
| Mar 19, 2002 | K013612 | INCARE PELVIC FLOOR THERAPY SYSTEM Hollister, Inc. | HIR |
| Mar 5, 2002 | K013653 | INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE Hollister, Inc. | HIR |
| May 21, 2001 | K002043 | PELVEX HOMETRAINER Purdue Technology Park | HIR |
| Apr 5, 2001 | K002617 | PERIFORM PERINEOMETRIC PROBE, MODEL 8300 Neen Design , Ltd., GB | HIR |
| Dec 27, 2000 | K002830 | PELVIC MUSCLE THERAPY Colonial Medical Supply | HIR |
| Nov 29, 2000 | K002834 | SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR Srs Medical Systems, Inc. | HIR |
| Mar 1, 2000 | K994079 | REFLEX TREATMENT SYSTEM Deschutes Medical Products, Inc. | HIR |
| Jan 10, 2000 | K993411 | FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR Mega Electronics , Ltd. | HIR |
| Nov 20, 1998 | K981277 | PERIFORM Verimed Holdings, Inc. | HIR |
| Oct 19, 1998 | K983052 | PERITRON PERINEOMETER MODEL 9300V OR 9300A Cardio Design Pty. , Ltd., AU | HIR |
| Dec 22, 1997 | K974036 | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE The Prometheus Group | HIR |
| Aug 11, 1997 | K970145 | PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) Biosearch Medical Products, Inc. | HIR |
| Jan 16, 1997 | K960508 | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 The Prometheus Group | HIR |
| Apr 18, 1996 | K960311 | PERINEOMETER Hollister, Inc. | HIR |
| Feb 8, 1996 | K945611 | PERITRON Cardio Design Pty. , Ltd. | HIR |
| Dec 6, 1995 | K952688 | INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE Empi | HIR |
| Sep 29, 1995 | K925681 | MYOTRAC2D/CS Thought Technology , Ltd., CA | HIR |
| Aug 9, 1995 | K934552 | PERIPUMP Deschutes Medical Products, Inc. | HIR |
| Jul 14, 1995 | K945937 | TE-800 PELVIC FLOOR EXERCISER Myo/Kinetic Systems, Inc. | HIR |
| Jun 6, 1995 | K942563 | ELITE BIOFEEDBACK Laborie Medical Technologies, Ltd. | HIR |
| May 11, 1995 | K935213 | INCONTROL Thought Technology , Ltd., CA | HIR |
| May 11, 1995 | K932149 | THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE Thought Technology , Ltd., CA | HIR |
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