Panels › Gastroenterology, Urology › Product code LKY · Class 2
Device, External Penile Rigidity
Regulation 876.5020
0510(k)s in 12 months (87 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LKY
| Company | 510(k)s | Recalls |
|---|---|---|
| Pos-T-Vac, Inc. | 11 | 0 |
| Nanma Mfg Co., Ltd. | 9 | 0 |
| Ercons, Inc. | 6 | 0 |
| Vts, Inc. | 5 | 0 |
| Walling Medical Equipment Co. | 4 | 0 |
| Dacomed Corp. | 2 | 0 |
| Imagyn Medical Technologies, Inc. | 2 | 0 |
| Numedtec, Inc. | 2 | 0 |
| Osbon Medical Systems, Ltd. | 2 | 0 |
| Owen Mumford USA, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2004 | K041573 | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S Nanma Mfg Co., Ltd. | LKY |
| Oct 3, 2003 | K032776 | VACURECT VACUUM CONSTRICTION DEVICE Vacurect Manufacturing (Pty) , Ltd. | LKY |
| Aug 6, 2003 | K030119 | NANMA ADJUSTABLE CONSTRICTION RING Nanma Mfg Co., Ltd. | LKY |
| Jun 3, 2003 | K030913 | NANMA VACUUM PUMP Nanma Mfg Co., Ltd. | LKY |
| Dec 20, 2002 | K013113 | MODIFICATION TO NANMA VACUUM PUMP Nanma Mfg Co., Ltd. | LKY |
| Aug 22, 2002 | K013051 | NANMA ADJUSTABLE CONSTRICTION RING Nanma Mfg Co., Ltd. | LKY |
| Jun 5, 2002 | K020969 | VACURECT VACUUM CONSTRICTION DEVICE Vacurect Manufacturing (Pty) , Ltd. | LKY |
| May 9, 2002 | K013053 | MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING Nanma Mfg Co., Ltd. | LKY |
| Apr 4, 2002 | K020258 | SUPPORT SLEEVE Pos-T-Vac, Inc. | LKY |
| Apr 4, 2002 | K020154 | VT-1 Pos-T-Vac, Inc. | LKY |
| Feb 5, 2002 | K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM Endocare, Inc. | LKY |
| Nov 9, 2001 | K012672 | BOSS-2000-2 VACUUM ERECTION DEVICE Pos-T-Vac, Inc. | LKY |
| Nov 9, 2001 | K012670 | BOSS 2000-3 VACUUM ERECTION DEVICE Pos-T-Vac, Inc. | LKY |
| Nov 9, 2001 | K012662 | SE-100 VACUUM ERECTION DEVICE Vts, Inc. | LKY |
| Nov 9, 2001 | K012639 | SE-300 VACUUM THERAPY SYSTEM Vts, Inc. | LKY |
| Nov 9, 2001 | K012620 | SE-200 Vts, Inc. | LKY |
| Nov 9, 2001 | K012619 | VT-1 Vts, Inc. | LKY |
| Jan 11, 2001 | K001859 | PENILE CONSTRICTOR RING Basic Solutions, LLC | LKY |
| Dec 19, 2000 | K003115 | ACTIS ADJUSTABLE CONSTRICTION LOOP Vivus, Inc. | LKY |
| Oct 19, 2000 | K000730 | IMPOAID Impoaid, Inc. | LKY |
| Jul 19, 2000 | K993909 | NANMA VACUUM PUMP Nanma Mfg Co., Ltd. | LKY |
| Jul 10, 2000 | K000124 | SENSATION -VACUUM ASSIST DEVICES Prosurg, Inc. | LKY |
| Mar 20, 2000 | K993343 | ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS Erecxel Enterprises | LKY |
| Jan 31, 2000 | K993908 | NANMA AJUSTABLE CONSTRICTION RING Nanma Mfg Co., Ltd. | LKY |
| Jan 31, 2000 | K993906 | NANMA NON-ADJUSTABLE CONSTRICTION RING Nanma Mfg Co., Ltd. | LKY |
| Dec 27, 1999 | K993143 | VITALITY SYSTEM Soma Blue, Inc. | LKY |
| Dec 27, 1999 | K993142 | ELITE CUSTOM Soma Blue, Inc. | LKY |
| Oct 5, 1999 | K992442 | V.T.S., INC. (V.T.-3) Vts, Inc. | LKY |
| Feb 24, 1999 | K990008 | ERCO-RIBBON -C Ercons, Inc. | LKY |
| Feb 24, 1999 | K990006 | ERCO-VAC -C Ercons, Inc. | LKY |
| Feb 8, 1999 | K983438 | MAX IT Dorea, Inc. | LKY |
| Dec 4, 1998 | K982275 | RAPPORT V.T.D. Owen Mumford USA, Inc. | LKY |
| Nov 24, 1998 | K981357 | ERCO-VAC Ercons, Inc. | LKY |
| Nov 24, 1998 | K981343 | ERCO-RIBBON Ercons, Inc. | LKY |
| Nov 2, 1998 | K983246 | POS-T-VAC (IVP-600) Pos-T-Vac, Inc. | LKY |
| Nov 2, 1998 | K983245 | POS-T-VAC (AVP-1000) Pos-T-Vac, Inc. | LKY |
| Aug 28, 1998 | K981180 | REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT Pos-T-Vac, Inc. | LKY |
| Aug 28, 1998 | K981011 | POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) Pos-T-Vac, Inc. | LKY |
| Jun 25, 1998 | K981506 | RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) Repro-Med Systems, Inc. | LKY |
| Jun 25, 1998 | K980948 | VED VALU- VACUUM ERECTION DEVICE Mission Pharmacal Comp | LKY |
| May 12, 1998 | K974196 | MEGAVAC SYSTEM Barry J. Kaplan, Inc. | LKY |
| May 6, 1998 | K980752 | XTEND Walling Medical Equipment Co. | LKY |
| May 6, 1998 | K980567 | CHARGER (ED) Walling Medical Equipment Co. | LKY |
| Mar 11, 1998 | K980291 | IMPOWER EXTERNAL VACUUM SYSTEM Imagyn Medical Technologies, Inc. | LKY |
| Feb 27, 1998 | K974082 | THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE Performance Plus, Inc. | LKY |
| Feb 25, 1998 | K974173 | ERECAID SYSTEM/STAY EREC SYSTEM Imagyn Medical Technologies, Inc. | LKY |
| Feb 19, 1998 | K974215 | VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET Vetco, Inc. | LKY |
| Jan 9, 1998 | K974470 | VTU-E VACUUM ERECTION SYSTEM Encore, Inc. | LKY |
| Nov 3, 1997 | K972537 | ERCO-VAC Ercons, Inc. | LKY |
| Oct 28, 1997 | K972353 | ERCO-RIBBON Ercons, Inc. | LKY |
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