Company ยท US
Empi
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2010. Name variants (Inc, Corp, punctuation) are merged.
60510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 17 |
| EGJ | Device, Iontophoresis, Other Uses | 11 |
| GXY | Electrode, Cutaneous | 10 |
| IPF | Stimulator, Muscle, Powered | 8 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 8 |
| HIR | Perineometer | 2 |
| BXB | Exerciser, Powered | 1 |
| GZI | Stimulator, Neuromuscular, External Functional | 1 |
| KGX | Tape And Bandage, Adhesive | 1 |
| LIH | Interferential Current Therapy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2010 | K093324 | EMPI CONTINUUM Empi | IPF |
| Jun 5, 2009 | K090922 | EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR Empi | GZJ |
| Nov 16, 2007 | K072946 | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM Empi | EGJ |
| May 14, 2007 | K070427 | DUPEL TRANSPORT IONTOPHORESIS SYSTEM Empi | EGJ |
| Jan 22, 2007 | K061650 | SELECT TENS, MODEL 4600S Empi | GZJ |
| Jan 21, 2005 | K041920 | INFINITY PLUS ELECTROTHERAPY SYSTEM Empi | IPF |
| Dec 17, 2004 | K042057 | INFINITY ELECTROTHERAPY SYSTEM Empi | LIH |
| Apr 8, 2003 | K030395 | EMPI ACTION PATCH IONTOPHORESIS SYSTEM Empi | EGJ |
| Jun 18, 2002 | K021100 | 300 PV COMPLETE ELECTROTHERAPY SYSTEM Empi | IPF |
| Sep 10, 1999 | K991991 | DUPEL IONTOPHORESIS SYSTEM Empi | EGJ |
| Dec 28, 1998 | K983484 | DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE Empi | EGJ |
| Nov 3, 1998 | K983206 | SMALL VAGINAL/RECTAL ELECTRODE Empi | KPI |
| Aug 14, 1997 | K972054 | INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE Empi | KPI |
| Jun 30, 1997 | K971527 | INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM Empi | KPI |
| May 30, 1997 | K970491 | DUPEL II BUFFERED IONTOPHORESIS ELECTRODES Empi | EGJ |
| Apr 22, 1997 | K970307 | MINNOVA PELVIC FLOOR STIMULATION SYSTEM Empi | KPI |
| Apr 14, 1997 | K970203 | EPIX VT Empi | GZJ |
| Jan 24, 1997 | K964577 | INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) Empi | KPI |
| May 17, 1996 | K951951 | FOCUS MODEL 795 UNIT Empi | GZJ |
| Apr 15, 1996 | K954272 | INNOVA RECTAL STIMULATON ELECTRODE Empi | KPI |
| Mar 20, 1996 | K951903 | EPIX XL TENS UNIT Empi | GZJ |
| Dec 6, 1995 | K952688 | INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE Empi | HIR |
| Jan 20, 1995 | K941911 | INNOVA PELVIC FLOOR STIMULATION SYSTEM Empi | KPI |
| Dec 29, 1994 | K940091 | INNOVA VAGINAL EMG SENSING ELECTRODE Empi | HIR |
| Aug 23, 1994 | K941389 | EMPI TAPE PATCHES Empi | KGX |
| Jul 15, 1994 | K915444 | DUPEL IONTOPHORESIS DEVICE Empi | EGJ |
| Nov 15, 1991 | K912015 | TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 Empi | EGJ |
| Oct 28, 1991 | K912014 | TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2 Empi | EGJ |
| Jul 15, 1991 | K910081 | TBD Empi | KPI |
| Oct 11, 1990 | K903093 | IONTOPHORESIS DEVICE Empi | EGJ |
| Jun 8, 1990 | K902195 | TBD TENS REUSABLE ELECTRODE Empi | GXY |
| Mar 23, 1990 | K901103 | MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE Empi | GXY |
| Mar 23, 1990 | K901102 | MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE Empi | GXY |
| Feb 26, 1990 | K896703 | TBD IONTOPHORESIS ELECTRODE Empi | EGJ |
| Dec 21, 1989 | K896485 | MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN Empi | GXY |
| Jun 1, 1989 | K890604 | EMPI, MODEL 489, TENS Empi | GZJ |
| Mar 16, 1989 | K890747 | EMPI REUSEABLE PIN-STYLE TENS ELECTRODE Empi | GXY |
| Mar 16, 1989 | K890614 | EMPI MULTIDAY TENS DISPOSABLE ELECTRODE Empi | GXY |
| Mar 16, 1989 | K890605 | EMPI ISLAND TENS ELECTRODE Empi | GXY |
| Sep 22, 1988 | K882631 | EMPI MODEL 727,NMS Empi | GZJ |
| Apr 15, 1988 | K881114 | EMPI MODEL 989, TENS Empi | GZJ |
| Apr 1, 1987 | K870168 | EMPI LOGIX MODEL 712 NMS, TENS Empi | GZJ |
| Dec 2, 1986 | K864010 | EMPI MODEL 712, LOGIX(TM), NMS Empi | IPF |
| Aug 27, 1986 | K862231 | EMPI, MODEL 1000 HAND HELD ELECTRODE Empi | GXY |
| Jul 15, 1986 | K861830 | EMPI MODEL GLS 450, TENS Empi | GZJ |
| Jul 3, 1986 | K861451 | EMPI MODEL 720 NMS, TENS Empi | GZJ |
| Feb 12, 1986 | K854775 | EMPI MODEL 730 NMS Empi | IPF |
| Feb 12, 1986 | K854774 | EMPI MODEL 720 NMS Empi | IPF |
| Dec 6, 1985 | K854513 | EMPI, NMS/SUE CUTANEOUS ELECTRODE Empi | GXY |
| Jul 17, 1985 | K851331 | EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) Empi | BXB |
Newest 50 of 60.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||