Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Perineometer

FDA product code HIR · 60 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.1425
Review panel: GU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-01-03 – 2026-04-27

HIR 2026-04-27

Pelvic Floor Exerciser (PF01)

Applicant Hunan Accurate Bio-Medical Technology Co., Ltd.

K number K252748

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HIR 2024-08-01

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

Applicant Pelvital USA, Inc.

K number K240805

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HIR 2024-02-22

Vaginal Tactile Ultrasound Imager

Applicant Advanced Tactile Imaging, Inc.

K number K231875

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HIR 2023-12-29

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

Applicant Pelvital USA, Inc.

K number K233362

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HIR 2023-12-20

Perifit Care+

Applicant X6 Innovations

K number K231780

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HIR 2023-02-10

Perifit

Applicant X6 Innovations

K number K221476

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HIR 2022-06-30

leva Pelvic Health System

Applicant Renovia, Inc.

K number K213913

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HIR 2021-09-21

Flyte

Applicant Pelvital USA, Inc.

K number K212655

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HIR 2021-09-08

Leva Pelvic Health System

Applicant Renovia, Inc.

K number K212495

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HIR 2021-04-13

Flyte

Applicant Pelvital USA, Inc.

K number K210764

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HIR 2020-08-24

Intimate Rose Kegel Exercise System

Applicant Plus EV Holdings Dba Intimate Rose

K number K193364

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HIR 2020-07-10

Pelvital System

Applicant Pelvital USA, Inc.

K number K200409

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HIR 2019-11-22

LEva Pelvic Digital Health System

Applicant Renovia, Inc.

K number K192270

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HIR 2018-04-04

leva Pelvic Floor Trainer

Applicant Renovia, Inc.

K number K180637

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HIR 2017-08-29

Feminine Personal Trainer (FPT)

Applicant Ralston Group

K number K171896

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HIR 2017-06-08

Vibrance Pelvic Trainer

Applicant Bioinfinity (M) Sdn. Bhd.

K number K162689

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HIR 2016-07-11

PeriCoach OTC

Applicant Analytica, Ltd.

K number K160758

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HIR 2013-10-04

INNER PEACE

Applicant Kamabry, Inc., Dba Inner Peace For Women

K number K122800

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HIR 2013-06-06

NATRATONE

Applicant Orelle Corporation, Ltd.

K number K121902

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HIR 2009-05-29

EXTT-101

Applicant Apimeds, Inc.

K number K082436

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HIR 2002-12-26

KEGELMASTER 2000

Applicant Kegelmaster 2000 , Ltd.

K number K023305

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HIR 2002-12-20

GYNEFLEX

Applicant Naissance Holdings, LC

K number K021115

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HIR 2002-03-20

PELVICFLEXER EXERCISE DEVICE

Applicant Pelvicflex, Inc.

K number K011688

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HIR 2002-03-19

INCARE PELVIC FLOOR THERAPY SYSTEM

Applicant Hollister, Inc.

K number K013612

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HIR 2002-03-05

INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE

Applicant Hollister, Inc.

K number K013653

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HIR 2001-05-21

PELVEX HOMETRAINER

Applicant Purdue Technology Park

K number K002043

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HIR 2001-04-05

PERIFORM PERINEOMETRIC PROBE, MODEL 8300

Applicant Neen Design , Ltd.

K number K002617

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HIR 2000-12-27

PELVIC MUSCLE THERAPY

Applicant Colonial Medical Supply

K number K002830

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HIR 2000-11-29

SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR

Applicant Srs Medical Systems, Inc.

K number K002834

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HIR 2000-03-01

REFLEX TREATMENT SYSTEM

Applicant Deschutes Medical Products, Inc.

K number K994079

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HIR 2000-01-10

FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR

Applicant Mega Electronics , Ltd.

K number K993411

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HIR 1998-11-20

PERIFORM

Applicant Verimed Holdings, Inc.

K number K981277

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HIR 1998-10-19

PERITRON PERINEOMETER MODEL 9300V OR 9300A

Applicant Cardio Design Pty. , Ltd.

K number K983052

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HIR 1997-12-22

PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE

Applicant The Prometheus Group

K number K974036

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HIR 1997-08-11

PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)

Applicant Biosearch Medical Products, Inc.

K number K970145

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HIR 1997-01-16

PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25

Applicant The Prometheus Group

K number K960508

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HIR 1996-04-18

PERINEOMETER

Applicant Hollister, Inc.

K number K960311

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HIR 1996-02-08

PERITRON

Applicant Cardio Design Pty. , Ltd.

K number K945611

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HIR 1995-12-06

INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE

Applicant Empi

K number K952688

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HIR 1995-09-29

MYOTRAC2D/CS

Applicant Thought Technology , Ltd.

K number K925681

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HIR 1995-08-09

PERIPUMP

Applicant Deschutes Medical Products, Inc.

K number K934552

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HIR 1995-07-14

TE-800 PELVIC FLOOR EXERCISER

Applicant Myo/Kinetic Systems, Inc.

K number K945937

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HIR 1995-06-06

ELITE BIOFEEDBACK

Applicant Laborie Medical Technologies, Ltd.

K number K942563

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HIR 1995-05-11

INCONTROL

Applicant Thought Technology , Ltd.

K number K935213

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HIR 1995-05-11

THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE

Applicant Thought Technology , Ltd.

K number K932149

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HIR 1994-12-29

INNOVA VAGINAL EMG SENSING ELECTRODE

Applicant Empi

K number K940091

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HIR 1994-08-26

EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE)

Applicant Sandhill Scientific, Inc.

K number K926218

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HIR 1992-06-16

VERIMED PERINEOMETER

Applicant Verimed Holdings, Inc.

K number K913912

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HIR 1991-07-26

PERRYMETER(TM)

Applicant Perrymeter Systems

K number K911190

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HIR 1989-10-05

EXTACISER PERINEAL MUSCLE EXERCISER

Applicant Bivona Medical Technologies

K number K892888

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HIR 1989-08-23

CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI

Applicant Hollister, Inc.

K number K891774

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HIR 1986-07-31

MILEX KEGEL PERINEAL EXERCISER

Applicant Milex Products, Inc.

K number K862410

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HIR 1986-07-31

VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363

Applicant Peritone Research, Ltd.

K number K861858

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HIR 1986-06-09

ELECTRO-MYOGRAPHIC PERINEOMETER

Applicant Verimed Holdings, Inc.

K number K854193

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HIR 1986-06-02

MONSANTO SANTOPRENE (PERITONE DEVICE)

Applicant Peritone Research, Ltd.

K number K861683

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HIR 1986-04-17

PERITONE DISPOSAL SHEATH - RUBBER AND VINYL

Applicant Laurie Ann Kaiser, Ph.D.

K number K860552

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HIR 1982-07-13

PP-100, PERSONAL PERINEOMETER

Applicant Farrall Instruments, Inc.

K number K821664

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HIR 1980-04-16

PERITONE

Applicant Laurie Ann Kaiser, Ph.D.

K number K800191

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HIR 1980-03-03

ELECTRONIC PERINEOMETER

Applicant Associates IN Biofeedback

K number K800303

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HIR 1979-01-03

VAGATEX

Applicant Vagatex

K number K782083

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