Product Code: HIR FDA class 2 21 CFR 884.1425

Perineometer

Obstetrics/Gynecology

The Perineometer is a diagnostic instrument used to measure the strength and endurance of pelvic floor muscles, particularly the vaginal and perineal musculature, often employed in assessment and biofeedback therapy for pelvic floor disorders. It is classified as FDA Class 2, meaning it poses moderate risk and requires 510(k) premarket clearance demonstrating substantial equivalence to a legally marketed predicate device. The product code is HIR, regulated under 21 CFR 884.1425, within the Obstetrics/Gynecology medical specialty, reviewed by the Genitourinary panel. No special risk flags apply to this device.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: HIR
Device Class: FDA class 2
Regulation Number: 884.1425
Medical Specialty: Obstetrics/Gynecology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 65 510(k) clearances via K numbers.

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