HIR · Class II · 21 CFR 884.1425

FDA Product Code HIR: Perineometer

Leading manufacturers include Pelvital USA, Inc., Renovia, Inc. and Hollister, Inc..

65
Total
65
Cleared
212d
Avg days
1979
Since
65 devices
25–48 of 65
Cleared May 29, 2009
EXTT-101
K082436
Apimeds, Inc.
Gastroenterology & Urology · 277d
Cleared Dec 26, 2002
KEGELMASTER 2000
K023305
Kegelmaster 2000 , Ltd.
Gastroenterology & Urology · 84d
Cleared Dec 20, 2002
GYNEFLEX
K021115
Naissance Holdings, LC
Gastroenterology & Urology · 256d
Cleared Mar 20, 2002
PELVICFLEXER EXERCISE DEVICE
K011688
Pelvicflex, Inc.
Gastroenterology & Urology · 293d
Cleared Mar 19, 2002
INCARE PELVIC FLOOR THERAPY SYSTEM
K013612
Hollister, Inc.
Gastroenterology & Urology · 134d
Cleared Mar 05, 2002
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
K013653
Hollister, Inc.
Gastroenterology & Urology · 119d
Cleared May 21, 2001
PELVEX HOMETRAINER
K002043
Purdue Technology Park
Gastroenterology & Urology · 320d
Cleared Apr 05, 2001
PERIFORM PERINEOMETRIC PROBE, MODEL 8300
K002617
Neen Design , Ltd.
Gastroenterology & Urology · 225d
Cleared Dec 27, 2000
PELVIC MUSCLE THERAPY
K002830
Colonial Medical Supply
Gastroenterology & Urology · 107d
Cleared Nov 29, 2000
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
K002834
Srs Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Mar 01, 2000
REFLEX TREATMENT SYSTEM
K994079
Deschutes Medical Products, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 10, 2000
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
K993411
Mega Electronics , Ltd.
Gastroenterology & Urology · 90d
Cleared Nov 20, 1998
PERIFORM
K981277
Verimed Holdings, Inc.
Gastroenterology & Urology · 226d
Cleared Oct 19, 1998
PERITRON PERINEOMETER MODEL 9300V OR 9300A
K983052
Cardio Design Pty. , Ltd.
Gastroenterology & Urology · 48d
Cleared Dec 22, 1997
PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
K974036
The Prometheus Group
Gastroenterology & Urology · 59d
Cleared Aug 11, 1997
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
K970145
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 208d
Cleared Jan 16, 1997
PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
K960508
The Prometheus Group
Gastroenterology & Urology · 346d
Cleared Apr 18, 1996
PERINEOMETER
K960311
Hollister, Inc.
Gastroenterology & Urology · 87d
Cleared Feb 08, 1996
PERITRON
K945611
Cardio Design Pty. , Ltd.
Gastroenterology & Urology · 450d
Cleared Dec 06, 1995
INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE
K952688
Empi
Gastroenterology & Urology · 177d
Cleared Sep 29, 1995
MYOTRAC2D/CS
K925681
Thought Technology , Ltd.
Gastroenterology & Urology · 1081d
Cleared Aug 09, 1995
PERIPUMP
K934552
Deschutes Medical Products, Inc.
Gastroenterology & Urology · 687d
Cleared Jul 14, 1995
TE-800 PELVIC FLOOR EXERCISER
K945937
Myo/Kinetic Systems, Inc.
Gastroenterology & Urology · 221d
Cleared Jun 06, 1995
ELITE BIOFEEDBACK
K942563
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 371d