FDA 510(k) Applications Submitted by EMPI

FDA 510(k) Number Submission Date Device Name Applicant
K800380 02/22/1980 FES ORTHOSIS MODEL NO. 2000 EMPI
K841045 03/12/1984 EMPI MODEL 984 BASIX, TENS EMPI
K841382 04/02/1984 EMPI MODEL 712, LOGIX, NMS EMPI
K801112 05/12/1980 EMPI MODEL 910S, TENS EMPI
K811395 05/18/1981 EMPI MODEL 710, NMS EMPI
K822224 07/27/1982 EMPI SINGLE USE EMPI
K771885 10/05/1977 IMPORTED PAIN CONTROL DEVICE EMPI
K802507 10/15/1980 TENSMATE EMPIMODEL 9980 EMPI
K792522 12/06/1979 MODEL 980D TENS NEUROPACER EMPI
K813501 12/14/1981 TRANSCUTANEOUS ELEC. NERVE STIMULATOR EMPI
K061650 06/13/2006 SELECT TENS, MODEL 4600S EMPI
K970307 01/27/1997 MINNOVA PELVIC FLOOR STIMULATION SYSTEM EMPI
K972054 06/02/1997 INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE EMPI
K983206 09/14/1998 SMALL VAGINAL/RECTAL ELECTRODE EMPI
K983484 10/05/1998 DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE EMPI
K964577 11/14/1996 INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) EMPI
K971527 04/28/1997 INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM EMPI
K881114 03/15/1988 EMPI MODEL 989, TENS EMPI
K861451 04/18/1986 EMPI MODEL 720 NMS, TENS EMPI
K851331 04/04/1985 EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) EMPI
K861830 05/13/1986 EMPI MODEL GLS 450, TENS EMPI
K862231 06/11/1986 EMPI, MODEL 1000 HAND HELD ELECTRODE EMPI
K882631 06/27/1988 EMPI MODEL 727,NMS EMPI
K854513 11/12/1985 EMPI, NMS/SUE CUTANEOUS ELECTRODE EMPI
K854775 11/29/1985 EMPI MODEL 730 NMS EMPI
K854774 11/29/1985 EMPI MODEL 720 NMS EMPI
K093324 10/23/2009 EMPI CONTINUUM EMPI
K991991 06/14/1999 DUPEL IONTOPHORESIS SYSTEM EMPI
K041920 07/16/2004 INFINITY PLUS ELECTROTHERAPY SYSTEM EMPI
K042057 07/30/2004 INFINITY ELECTROTHERAPY SYSTEM EMPI
K890747 02/13/1989 EMPI REUSEABLE PIN-STYLE TENS ELECTRODE EMPI
K902195 05/16/1990 TBD TENS REUSABLE ELECTRODE EMPI
K870168 01/14/1987 EMPI LOGIX MODEL 712 NMS, TENS EMPI
K864010 10/15/1986 EMPI MODEL 712, LOGIX(TM), NMS EMPI
K070427 02/13/2007 DUPEL TRANSPORT IONTOPHORESIS SYSTEM EMPI
K090922 04/01/2009 EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR EMPI
K072946 10/17/2007 HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM EMPI
K021100 04/04/2002 300 PV COMPLETE ELECTROTHERAPY SYSTEM EMPI
K951951 04/26/1995 FOCUS MODEL 795 UNIT EMPI
K910081 01/09/1991 TBD EMPI
K970203 01/21/1997 EPIX VT EMPI
K890604 02/06/1989 EMPI, MODEL 489, TENS EMPI
K890605 02/06/1989 EMPI ISLAND TENS ELECTRODE EMPI
K890614 02/07/1989 EMPI MULTIDAY TENS DISPOSABLE ELECTRODE EMPI
K970491 02/10/1997 DUPEL II BUFFERED IONTOPHORESIS ELECTRODES EMPI
K901102 03/07/1990 MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE EMPI
K901103 03/07/1990 MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE EMPI
K941389 03/22/1994 EMPI TAPE PATCHES EMPI
K941911 04/19/1994 INNOVA PELVIC FLOOR STIMULATION SYSTEM EMPI
K951903 04/24/1995 EPIX XL TENS UNIT EMPI
K912014 05/06/1991 TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2 EMPI
K912015 05/06/1991 TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 EMPI
K952688 06/12/1995 INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE EMPI
K903093 07/13/1990 IONTOPHORESIS DEVICE EMPI
K954272 09/12/1995 INNOVA RECTAL STIMULATON ELECTRODE EMPI
K896485 11/13/1989 MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN EMPI
K896703 11/28/1989 TBD IONTOPHORESIS ELECTRODE EMPI
K915444 12/05/1991 DUPEL IONTOPHORESIS DEVICE EMPI
K940091 01/07/1994 INNOVA VAGINAL EMG SENSING ELECTRODE EMPI
K030395 02/05/2003 EMPI ACTION PATCH IONTOPHORESIS SYSTEM EMPI


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