Panels › Gastroenterology, Urology › Product code KPI · Class 2
Stimulator, Electrical, Non-Implantable, For Incontinence
Regulation 876.5320
7510(k)s in 12 months (97 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KPI
| Company | 510(k)s | Recalls |
|---|---|---|
| Hollister, Inc. | 10 | 0 |
| Empi | 8 | 0 |
| Incontrol Medical, LLC | 7 | 0 |
| BTL Industries, Inc. | 4 | 0 |
| The Prometheus Group | 4 | 0 |
| Shenzhen Konmed Technology Co., Ltd. | 4 | 0 |
| Tenscare, Ltd. | 4 | 0 |
| Utah Medical Products, Inc. | 4 | 0 |
| Athena Feminine Technologies, Inc. | 2 | 0 |
| Everyway Medical Instruments Co.,Ltd | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2007 | K070331 | UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES Laborie Medical Technologies | KPI |
| Mar 15, 2006 | K053434 | MYOTRAC INFINITI ELECTRICAL STIMULATOR Thought Technology , Ltd., CA | KPI |
| Dec 5, 2005 | K053007 | SKYLARK URO PROBE Skylark Device & Systems Co., Ltd., TW | KPI |
| Apr 12, 2005 | K050483 | EVADRI BLADDER CONTROL SYSTEMS Hollister, Inc. | KPI |
| Dec 30, 2003 | K033256 | ATHENA PELVIC MUSCLE TRAINER II Athena Feminine Technologies, Inc. | KPI |
| Dec 3, 2003 | K032988 | ELPHA 4 CONTI Danmeter A/S, DK | KPI |
| May 23, 2003 | K030039 | PATHWAY STM-10 PELVIC FLOOR STIMULATOR The Prometheus Group | KPI |
| Apr 30, 2003 | K023905 | ATHENA PELVIC MUSCLE TRAINER Athena Feminine Technologies, Inc. | KPI |
| Feb 19, 2003 | K023906 | PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM The Prometheus Group | KPI |
| Dec 19, 2001 | K013141 | MICROGYN PLUS STIMULATION DEVICE Hollister, Inc. | KPI |
| Jun 22, 2001 | K011435 | HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM Hmt, Inc., KR | KPI |
| Mar 22, 2001 | K002154 | K.E.A.T. Emd Electronic Medical Devices, Corp. | KPI |
| Aug 29, 2000 | K001903 | NEOCONTROL PELVIC FLOOR THERAPY SYSTEM Neotonus, Inc. | KPI |
| Aug 3, 2000 | K994109 | DETRUSAN 500 Innovamed USA, Inc. | KPI |
| Jul 31, 2000 | K001515 | PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 The Prometheus Group | KPI |
| Feb 22, 2000 | K993976 | PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR The Prometheus Group | KPI |
| Nov 29, 1999 | K993721 | UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES Laborie Medical Tech Corp. | KPI |
| Aug 5, 1999 | K990041 | UROSTYM BIOFEEDBACK AND STIMULATION PROBES Laborie Medical Tech Corp. | KPI |
| Mar 25, 1999 | K990456 | ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP Hollister, Inc. | KPI |
| Nov 3, 1998 | K983206 | SMALL VAGINAL/RECTAL ELECTRODE Empi | KPI |
| Jun 12, 1998 | K973096 | NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM Neotonus, Inc. | KPI |
| Dec 23, 1997 | K974048 | INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER Hollister, Inc. | KPI |
| Aug 14, 1997 | K972054 | INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE Empi | KPI |
| Aug 14, 1997 | K964738 | ELPHA 2000 CONTI Dan Med, Inc. | KPI |
| Jun 30, 1997 | K971527 | INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM Empi | KPI |
| Jun 25, 1997 | K971541 | VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON Hollister, Inc. | KPI |
| May 23, 1997 | K970077 | LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) Utah Medical Products, Inc. | KPI |
| May 20, 1997 | K962009 | UROSTYM Laborie Medical Technologies, Ltd. | KPI |
| Apr 22, 1997 | K970307 | MINNOVA PELVIC FLOOR STIMULATION SYSTEM Empi | KPI |
| Apr 15, 1997 | K970602 | VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL Hollister, Inc. | KPI |
| Feb 10, 1997 | K964526 | LIBERTY RECTAL PELVIC FLOOR EXERCISER Utah Medical Products, Inc. | KPI |
| Jan 24, 1997 | K964577 | INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) Empi | KPI |
| Oct 23, 1996 | K963222 | MICROGYN PLUS STIMULATION DEVICE Hollister, Inc. | KPI |
| Aug 9, 1996 | K961872 | INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER Hollister, Inc. | KPI |
| Jun 27, 1996 | K960496 | LIBERTY LITE PFS SYSTEM Utah Medical Products, Inc. | KPI |
| Apr 15, 1996 | K954272 | INNOVA RECTAL STIMULATON ELECTRODE Empi | KPI |
| Oct 17, 1995 | K930530 | INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC Hollister, Inc. | KPI |
| Apr 12, 1995 | K945292 | TS-700P CONTROL XP ELECTRICAL STIMULATOR Myo/Kinetic Systems, Inc. | KPI |
| Feb 9, 1995 | K943250 | LIBERTY Utah Medical Products, Inc. | KPI |
| Jan 20, 1995 | K941911 | INNOVA PELVIC FLOOR STIMULATION SYSTEM Empi | KPI |
| Oct 13, 1993 | K922562 | STIMTECH PFX, CATALOG NUMBER 78-8540 Stimtech Products | KPI |
| Jul 15, 1991 | K910081 | TBD Empi | KPI |
| Jun 7, 1990 | K891007 | NONIMPLANTED ELECTRICAL CONTINENCE DEVICE Tridak Division of Indicon, Inc. | KPI |
| Aug 23, 1989 | K891773 | MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI Hollister, Inc. | KPI |
| Feb 2, 1988 | K874867 | CATR(TM)-H CARDIOTOMY HOLDER Bentley Laboratories, Inc. | KPI |
| Apr 9, 1985 | K850167 | }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR Urologics, Inc. | KPI |
| Dec 16, 1976 | K761145 | RADIOISOTOPE CALIBRATOR (CRCO-22NB) G.D. Searle and Co. | KPI |
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