Atlas FDA

HIR

65 FDA 510(k) clearances · Product code

166 daysmedian time to decision
387 days90th percentile
65clearances measured

FDA profile

Official device name
Perineometer
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1425
Medical specialty
Obstetrics/Gynecology
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Pelvic Floor Exerciser (PF01) (K252748)Hunan Accurate Bio-Medical Technology Co., Ltd.2026-04-27
Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (K240805)Pelvital USA, Inc.2024-08-01
Vaginal Tactile Ultrasound Imager (K231875)Advanced Tactile Imaging, Inc.2024-02-22
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (K233362)Pelvital USA, Inc.2023-12-29
Perifit Care+ (K231780)X6 Innovations2023-12-20
Perifit (K221476)X6 Innovations2023-02-10
leva Pelvic Health System (K213913)Renovia, Inc.2022-06-30
Flyte (K212655)Pelvital USA, Inc.2021-09-21
Leva Pelvic Health System (K212495)Renovia, Inc.2021-09-08
Flyte (K210764)Pelvital USA, Inc.2021-04-13
Intimate Rose Kegel Exercise System (K193364)Plus EV Holdings Dba Intimate Rose2020-08-24
Pelvital System (K200409)Pelvital USA, Inc.2020-07-10
LEva Pelvic Digital Health System (K192270)Renovia, Inc.2019-11-22
leva Pelvic Floor Trainer (K180637)Renovia, Inc.2018-04-04
Feminine Personal Trainer (FPT) (K171896)Ralston Group2017-08-29
Vibrance Pelvic Trainer (K162689)Bioinfinity (M) Sdn. Bhd.2017-06-08
PeriCoach OTC (K160758)Analytica, Ltd.2016-07-11
Vaginal Tactile Imager (K142355)Advanced Tactile Imaging, Inc.2015-05-28
PeriCoach (K143580)Analytica, Ltd.2015-03-18
VIBRANCE KEGEL DEVICE (VKD) (K141893)Bioinfinity (M) Sdn. Bhd.2014-12-18
IEVA REHABILITATIVE POSITIONAL DEVICE (K133990)Remendium Labs, LLC2014-10-09
KEGEL SMART, KEGELSMART PEARL (K140780)Regulatory Insight, Inc.2014-09-10
INNER PEACE (K122800)Kamabry, Inc., Dba Inner Peace For Women2013-10-04
NATRATONE (K121902)Orelle Corporation, Ltd.2013-06-06
EXTT-101 (K082436)Apimeds, Inc.2009-05-29
KEGELMASTER 2000 (K023305)Kegelmaster 2000 , Ltd.2002-12-26
GYNEFLEX (K021115)Naissance Holdings, LC2002-12-20
PELVICFLEXER EXERCISE DEVICE (K011688)Pelvicflex, Inc.2002-03-20
INCARE PELVIC FLOOR THERAPY SYSTEM (K013612)Hollister, Inc.2002-03-19
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE (K013653)Hollister, Inc.2002-03-05
PELVEX HOMETRAINER (K002043)Purdue Technology Park2001-05-21
PERIFORM PERINEOMETRIC PROBE, MODEL 8300 (K002617)Neen Design , Ltd.2001-04-05
PELVIC MUSCLE THERAPY (K002830)Colonial Medical Supply2000-12-27
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR (K002834)Srs Medical Systems, Inc.2000-11-29
REFLEX TREATMENT SYSTEM (K994079)Deschutes Medical Products, Inc.2000-03-01
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR (K993411)Mega Electronics , Ltd.2000-01-10
PERIFORM (K981277)Verimed Holdings, Inc.1998-11-20
PERITRON PERINEOMETER MODEL 9300V OR 9300A (K983052)Cardio Design Pty. , Ltd.1998-10-19
PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE (K974036)The Prometheus Group1997-12-22
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) (K970145)Biosearch Medical Products, Inc.1997-08-11
PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 (K960508)The Prometheus Group1997-01-16
PERINEOMETER (K960311)Hollister, Inc.1996-04-18
PERITRON (K945611)Cardio Design Pty. , Ltd.1996-02-08
INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE (K952688)Empi1995-12-06
MYOTRAC2D/CS (K925681)Thought Technology , Ltd.1995-09-29
PERIPUMP (K934552)Deschutes Medical Products, Inc.1995-08-09
TE-800 PELVIC FLOOR EXERCISER (K945937)Myo/Kinetic Systems, Inc.1995-07-14
ELITE BIOFEEDBACK (K942563)Laborie Medical Technologies, Ltd.1995-06-06
INCONTROL (K935213)Thought Technology , Ltd.1995-05-11
THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE (K932149)Thought Technology , Ltd.1995-05-11
INNOVA VAGINAL EMG SENSING ELECTRODE (K940091)Empi1994-12-29
EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) (K926218)Sandhill Scientific, Inc.1994-08-26
VERIMED PERINEOMETER (K913912)Verimed Holdings, Inc.1992-06-16
PERRYMETER(TM) (K911190)Perrymeter Systems1991-07-26
EXTACISER PERINEAL MUSCLE EXERCISER (K892888)Bivona Medical Technologies1989-10-05
CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI (K891774)Hollister, Inc.1989-08-23
VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 (K861858)Peritone Research, Ltd.1986-07-31
MILEX KEGEL PERINEAL EXERCISER (K862410)Milex Products, Inc.1986-07-31
ELECTRO-MYOGRAPHIC PERINEOMETER (K854193)Verimed Holdings, Inc.1986-06-09
MONSANTO SANTOPRENE (PERITONE DEVICE) (K861683)Peritone Research, Ltd.1986-06-02
PERITONE DISPOSAL SHEATH - RUBBER AND VINYL (K860552)Laurie Ann Kaiser, Ph.D.1986-04-17
PP-100, PERSONAL PERINEOMETER (K821664)Farrall Instruments, Inc.1982-07-13
PERITONE (K800191)Laurie Ann Kaiser, Ph.D.1980-04-16
ELECTRONIC PERINEOMETER (K800303)Associates IN Biofeedback1980-03-03
VAGATEX (K782083)Vagatex1979-01-03

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