FDA 510(k) Applications Submitted by EMPI

FDA 510(k) Number Submission Date Device Name Applicant
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
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
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
K970203 01/21/1997 EPIX VT EMPI
K970491 02/10/1997 DUPEL II BUFFERED IONTOPHORESIS ELECTRODES EMPI
K951903 04/24/1995 EPIX XL TENS UNIT EMPI
K954272 09/12/1995 INNOVA RECTAL STIMULATON ELECTRODE EMPI
K030395 02/05/2003 EMPI ACTION PATCH IONTOPHORESIS SYSTEM EMPI


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