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
49–65 of 65
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 Jun 16, 1992
VERIMED PERINEOMETER
K913912
Verimed Holdings, Inc.
Gastroenterology & Urology · 292d
Cleared Jul 26, 1991
PERRYMETER(TM)
K911190
Perrymeter Systems
Gastroenterology & Urology · 130d
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
Cleared Jul 31, 1986
VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363
K861858
Peritone Research, Ltd.
Gastroenterology & Urology · 78d
Cleared Jul 31, 1986
MILEX KEGEL PERINEAL EXERCISER
K862410
Milex Products, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 09, 1986
ELECTRO-MYOGRAPHIC PERINEOMETER
K854193
Verimed Holdings, Inc.
Gastroenterology & Urology · 237d
Cleared Jun 02, 1986
MONSANTO SANTOPRENE (PERITONE DEVICE)
K861683
Peritone Research, Ltd.
Gastroenterology & Urology · 32d
Cleared Apr 17, 1986
PERITONE DISPOSAL SHEATH - RUBBER AND VINYL
K860552
Laurie Ann Kaiser, Ph.D.
Gastroenterology & Urology · 62d
Cleared Jul 13, 1982
PP-100, PERSONAL PERINEOMETER
K821664
Farrall Instruments, Inc.
Gastroenterology & Urology · 46d
Cleared Apr 16, 1980
PERITONE
K800191
Laurie Ann Kaiser, Ph.D.
Gastroenterology & Urology · 78d
Cleared Mar 03, 1980
ELECTRONIC PERINEOMETER
K800303
Associates IN Biofeedback
Gastroenterology & Urology · 21d
Cleared Jan 03, 1979
VAGATEX
K782083
Vagatex
Gastroenterology & Urology · 20d