FDA Product Code
FDA Product Code HIR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1425
510(k) Clearances — 65 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-04-27 | Traditional | PDF ↗ |
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. | 2024-08-01 | Traditional | PDF ↗ |
| K231875 | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | 2024-02-22 | Traditional | PDF ↗ |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | 2023-12-29 | Special | PDF ↗ |
| K231780 | Perifit Care+ | X6 Innovations | 2023-12-20 | Traditional | PDF ↗ |
| K221476 | Perifit | X6 Innovations | 2023-02-10 | Traditional | PDF ↗ |
| K213913 | leva Pelvic Health System | Renovia, Inc. | 2022-06-30 | Traditional | PDF ↗ |
| K212655 | Flyte | Pelvital USA, Inc. | 2021-09-21 | Special | PDF ↗ |
| K212495 | Leva Pelvic Health System | Renovia, Inc. | 2021-09-08 | Special | PDF ↗ |
| K210764 | Flyte | Pelvital USA, Inc. | 2021-04-13 | Special | PDF ↗ |
| K193364 | Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose | 2020-08-24 | Traditional | PDF ↗ |
| K200409 | Pelvital System | Pelvital USA, Inc. | 2020-07-10 | Traditional | PDF ↗ |
| K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | 2019-11-22 | Traditional | PDF ↗ |
| K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | 2018-04-04 | Traditional | PDF ↗ |
| K171896 | Feminine Personal Trainer (FPT) | Ralston Group | 2017-08-29 | Traditional | PDF ↗ |
| K162689 | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | 2017-06-08 | Traditional | PDF ↗ |
| K160758 | PeriCoach OTC | Analytica, Ltd. | 2016-07-11 | Traditional | PDF ↗ |
| K142355 | Vaginal Tactile Imager | Advanced Tactile Imaging, Inc. | 2015-05-28 | Traditional | PDF ↗ |
| K143580 | PeriCoach | Analytica, Ltd. | 2015-03-18 | Traditional | PDF ↗ |
| K141893 | VIBRANCE KEGEL DEVICE (VKD) | Bioinfinity (M) Sdn. Bhd. | 2014-12-18 | Traditional | PDF ↗ |
| K133990 | IEVA REHABILITATIVE POSITIONAL DEVICE | Remendium Labs, LLC | 2014-10-09 | Traditional | PDF ↗ |
| K140780 | KEGEL SMART, KEGELSMART PEARL | Regulatory Insight, Inc. | 2014-09-10 | Traditional | PDF ↗ |
| K122800 | INNER PEACE | Kamabry, Inc., Dba Inner Peace For Women | 2013-10-04 | Traditional | PDF ↗ |
| K121902 | NATRATONE | Orelle Corporation, Ltd. | 2013-06-06 | Traditional | PDF ↗ |
| K082436 | EXTT-101 | Apimeds, Inc. | 2009-05-29 | Traditional | PDF ↗ |
| K023305 | KEGELMASTER 2000 | Kegelmaster 2000 , Ltd. | 2002-12-26 | Traditional | PDF ↗ |
| K021115 | GYNEFLEX | Naissance Holdings, LC | 2002-12-20 | Traditional | PDF ↗ |
| K011688 | PELVICFLEXER EXERCISE DEVICE | Pelvicflex, Inc. | 2002-03-20 | Traditional | PDF ↗ |
| K013612 | INCARE PELVIC FLOOR THERAPY SYSTEM | Hollister, Inc. | 2002-03-19 | Traditional | PDF ↗ |
| K013653 | INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE | Hollister, Inc. | 2002-03-05 | Traditional | PDF ↗ |
| K002043 | PELVEX HOMETRAINER | Purdue Technology Park | 2001-05-21 | Traditional | PDF ↗ |
| K002617 | PERIFORM PERINEOMETRIC PROBE, MODEL 8300 | Neen Design , Ltd. | 2001-04-05 | Traditional | PDF ↗ |
| K002830 | PELVIC MUSCLE THERAPY | Colonial Medical Supply | 2000-12-27 | Traditional | PDF ↗ |
| K002834 | SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR | Srs Medical Systems, Inc. | 2000-11-29 | Traditional | PDF ↗ |
| K994079 | REFLEX TREATMENT SYSTEM | Deschutes Medical Products, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K993411 | FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR | Mega Electronics , Ltd. | 2000-01-10 | Traditional | PDF ↗ |
| K981277 | PERIFORM | Verimed Holdings, Inc. | 1998-11-20 | Traditional | PDF ↗ |
| K983052 | PERITRON PERINEOMETER MODEL 9300V OR 9300A | Cardio Design Pty. , Ltd. | 1998-10-19 | Traditional | PDF ↗ |
| K974036 | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE | The Prometheus Group | 1997-12-22 | Traditional | PDF ↗ |
| K970145 | PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) | Biosearch Medical Products, Inc. | 1997-08-11 | Traditional | PDF ↗ |
| K960508 | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 | The Prometheus Group | 1997-01-16 | Traditional | PDF ↗ |
| K960311 | PERINEOMETER | Hollister, Inc. | 1996-04-18 | Traditional | PDF ↗ |
| K945611 | PERITRON | Cardio Design Pty. , Ltd. | 1996-02-08 | Traditional | PDF ↗ |
| K952688 | INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE | Empi | 1995-12-06 | Traditional | PDF ↗ |
| K925681 | MYOTRAC2D/CS | Thought Technology , Ltd. | 1995-09-29 | Traditional | PDF ↗ |
| K934552 | PERIPUMP | Deschutes Medical Products, Inc. | 1995-08-09 | Traditional | PDF ↗ |
| K945937 | TE-800 PELVIC FLOOR EXERCISER | Myo/Kinetic Systems, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K942563 | ELITE BIOFEEDBACK | Laborie Medical Technologies, Ltd. | 1995-06-06 | Traditional | PDF ↗ |
| K935213 | INCONTROL | Thought Technology , Ltd. | 1995-05-11 | Traditional | PDF ↗ |
| K932149 | THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE | Thought Technology , Ltd. | 1995-05-11 | Traditional | PDF ↗ |
| K940091 | INNOVA VAGINAL EMG SENSING ELECTRODE | Empi | 1994-12-29 | Traditional | PDF ↗ |
| K926218 | EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) | Sandhill Scientific, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K913912 | VERIMED PERINEOMETER | Verimed Holdings, Inc. | 1992-06-16 | Traditional | PDF ↗ |
| K911190 | PERRYMETER(TM) | Perrymeter Systems | 1991-07-26 | Traditional | PDF ↗ |
| K892888 | EXTACISER PERINEAL MUSCLE EXERCISER | Bivona Medical Technologies | 1989-10-05 | Traditional | PDF ↗ |
| K891774 | CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI | Hollister, Inc. | 1989-08-23 | Traditional | PDF ↗ |
| K861858 | VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 | Peritone Research, Ltd. | 1986-07-31 | Traditional | PDF ↗ |
| K862410 | MILEX KEGEL PERINEAL EXERCISER | Milex Products, Inc. | 1986-07-31 | Traditional | PDF ↗ |
| K854193 | ELECTRO-MYOGRAPHIC PERINEOMETER | Verimed Holdings, Inc. | 1986-06-09 | Traditional | PDF ↗ |
| K861683 | MONSANTO SANTOPRENE (PERITONE DEVICE) | Peritone Research, Ltd. | 1986-06-02 | Traditional | PDF ↗ |
| K860552 | PERITONE DISPOSAL SHEATH - RUBBER AND VINYL | Laurie Ann Kaiser, Ph.D. | 1986-04-17 | Traditional | PDF ↗ |
| K821664 | PP-100, PERSONAL PERINEOMETER | Farrall Instruments, Inc. | 1982-07-13 | Traditional | PDF ↗ |
| K800191 | PERITONE | Laurie Ann Kaiser, Ph.D. | 1980-04-16 | Traditional | PDF ↗ |
| K800303 | ELECTRONIC PERINEOMETER | Associates IN Biofeedback | 1980-03-03 | Traditional | PDF ↗ |
| K782083 | VAGATEX | Vagatex | 1979-01-03 | Traditional | PDF ↗ |
Product code HIR · Class II · Obstetrics/Gynecology. Data: openFDA.