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 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 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 May 11, 1995
THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE
K932149
Thought Technology , Ltd.
Gastroenterology & Urology · 737d
Cleared May 11, 1995
INCONTROL
K935213
Thought Technology , Ltd.
Gastroenterology & Urology · 559d
Cleared Dec 29, 1994
INNOVA VAGINAL EMG SENSING ELECTRODE
K940091
Empi
Gastroenterology & Urology · 356d
Cleared Aug 26, 1994
EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE)
K926218
Sandhill Scientific, Inc.
Gastroenterology & Urology · 624d
Cleared Oct 05, 1989
EXTACISER PERINEAL MUSCLE EXERCISER
K892888
Bivona Medical Technologies
Gastroenterology & Urology · 168d
Cleared Aug 23, 1989
CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI
K891774
Hollister, Inc.
Gastroenterology & Urology · 152d