FDA 510(k) Applications for Medical Device Product Code "LKY"
(Device, External Penile Rigidity)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K971576 | AMERICAN MEDTECH | REJOYN PENILE SUPPORT SYSTEM | 10/16/1997 |
| K974196 | BARRY J. KAPLAN, INC. | MEGAVAC SYSTEM | 05/12/1998 |
| K001859 | BASIC SOLUTIONS, LLC. | PENILE CONSTRICTOR RING | 01/11/2001 |
| K983438 | DOREA, INC. | MAX IT | 02/08/1999 |
| K974470 | ENCORE, INC. | VTU-E VACUUM ERECTION SYSTEM | 01/09/1998 |
| K020082 | ENDOCARE, INC. | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM | 02/05/2002 |
| K972353 | ERCONS, INC. | ERCO-RIBBON | 10/28/1997 |
| K981343 | ERCONS, INC. | ERCO-RIBBON | 11/24/1998 |
| K990008 | ERCONS, INC. | ERCO-RIBBON -C | 02/24/1999 |
| K972537 | ERCONS, INC. | ERCO-VAC | 11/03/1997 |
| K981357 | ERCONS, INC. | ERCO-VAC | 11/24/1998 |
| K990006 | ERCONS, INC. | ERCO-VAC -C | 02/24/1999 |
| K993343 | ERECXEL ENTERPRISES | ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS | 03/20/2000 |
| K974173 | IMAGYN MEDICAL TECHNOLOGIES, INC. | ERECAID SYSTEM/STAY EREC SYSTEM | 02/25/1998 |
| K980291 | IMAGYN MEDICAL TECHNOLOGIES, INC. | IMPOWER EXTERNAL VACUUM SYSTEM | 03/11/1998 |
| K000730 | IMPOAID, INC. | IMPOAID | 10/19/2000 |
| K955856 | LABORIE MEDICAL TECHNOLOGIES, LTD. | TEX-AID BLUE | 02/16/1996 |
| K971257 | MCKENNA & CUNEO | VTU-1 VACUUM ERECTION SYSTEM | 10/03/1997 |
| K980948 | MISSION PHARMACAL COMP | VED VALU- VACUUM ERECTION DEVICE | 06/25/1998 |
| K013053 | NANMA MFG CO., LTD. | MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING | 05/09/2002 |
| K013113 | NANMA MFG CO., LTD. | MODIFICATION TO NANMA VACUUM PUMP | 12/20/2002 |
| K013051 | NANMA MFG CO., LTD. | NANMA ADJUSTABLE CONSTRICTION RING | 08/22/2002 |
| K030119 | NANMA MFG CO., LTD. | NANMA ADJUSTABLE CONSTRICTION RING | 08/06/2003 |
| K993908 | NANMA MFG CO., LTD. | NANMA AJUSTABLE CONSTRICTION RING | 01/31/2000 |
| K993906 | NANMA MFG CO., LTD. | NANMA NON-ADJUSTABLE CONSTRICTION RING | 01/31/2000 |
| K030913 | NANMA MFG CO., LTD. | NANMA VACUUM PUMP | 06/03/2003 |
| K993909 | NANMA MFG CO., LTD. | NANMA VACUUM PUMP | 07/19/2000 |
| K041573 | NANMA MFG CO., LTD. | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S | 08/25/2004 |
| K971443 | OWEN MUMFORD USA, INC. | RAPPORT V.T.D. | 09/26/1997 |
| K982275 | Owen Mumford USA, Inc. | RAPPORT V.T.D. | 12/04/1998 |
| K974082 | PERFORMANCE PLUS, INC. | THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE | 02/27/1998 |
| K012670 | POS-T-VAC, INC. | BOSS 2000-3 VACUUM ERECTION DEVICE | 11/09/2001 |
| K012672 | POS-T-VAC, INC. | BOSS-2000-2 VACUUM ERECTION DEVICE | 11/09/2001 |
| K983245 | POS-T-VAC, INC. | POS-T-VAC (AVP-1000) | 11/02/1998 |
| K983246 | POS-T-VAC, INC. | POS-T-VAC (IVP-600) | 11/02/1998 |
| K981011 | POS-T-VAC, INC. | POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) | 08/28/1998 |
| K960342 | POS-T-VAC, INC. | POS-T-VAC AVP-1000 & MVP-700 | 03/01/1996 |
| K960828 | POS-T-VAC, INC. | POS-T-VAC B-10 BAND KIT | 03/08/1996 |
| K981180 | POS-T-VAC, INC. | 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 | 08/28/1998 |
| K020258 | POS-T-VAC, INC. | SUPPORT SLEEVE | 04/04/2002 |
| K020154 | POS-T-VAC, INC. | VT-1 | 04/04/2002 |
| K000124 | PROSURG, INC. | SENSATION -VACUUM ASSIST DEVICES | 07/10/2000 |
| K981506 | REPRO-MED SYSTEMS, INC. | RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) | 06/25/1998 |
| K993142 | SOMA BLUE, INC. | ELITE CUSTOM | 12/27/1999 |
| K993143 | SOMA BLUE, INC. | VITALITY SYSTEM | 12/27/1999 |
| K012620 | V.T.S.,INC. | SE-200 | 11/09/2001 |
| K992442 | V.T.S.,INC. | V.T.S., INC. (V.T.-3) | 10/05/1999 |
| K012619 | V.T.S.,INC. | VT-1 | 11/09/2001 |
| K020969 | VACURECT MANUFACTURING (PTY) LTD. | VACURECT VACUUM CONSTRICTION DEVICE | 06/05/2002 |
| K032776 | VACURECT MANUFACTURING (PTY) LTD. | VACURECT VACUUM CONSTRICTION DEVICE | 10/03/2003 |
| K974215 | VETCO, INC. | VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET | 02/19/1998 |
| K962915 | VIVUS, INC. | ACTIS (VENOUS FLOW CONTROLLER) | 12/10/1996 |
| K003115 | VIVUS, INC. | ACTIS ADJUSTABLE CONSTRICTION LOOP | 12/19/2000 |
| K012662 | VTS, INC. | SE-100 VACUUM ERECTION DEVICE | 11/09/2001 |
| K012639 | VTS, INC. | SE-300 VACUUM THERAPY SYSTEM | 11/09/2001 |
| K980567 | WALLING MEDICAL EQUIPMENT CO. | CHARGER (ED) | 05/06/1998 |
| K971768 | WALLING MEDICAL EQUIPMENT CO. | RELIANT CHARGER | 09/29/1997 |
| K980752 | WALLING MEDICAL EQUIPMENT CO. | XTEND | 05/06/1998 |
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