FDA 510(k) Applications for Medical Device Product Code "LKY"
(Device, External Penile Rigidity)

FDA 510(k) Number Applicant Device Name Decision Date
K971443 *OWNE MUMFORD USA, INC.** RAPPORT V.T.D. 09/26/1997
K982275 *OWNE MUMFORD USA, INC.** RAPPORT V.T.D. 12/04/1998
K932397 ALLAN WALLING MEDICAL EQUIPMENT CO. RELIANT 03/07/1994
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
K896061 CLYDE ENGINEERING SERVICE ERECTION DEVICE 03/07/1990
K920409 DACOMED CORP. DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE 05/11/1992
K900774 DACOMED CORP. DACOMED NEGATIVE PRESSURE ERECTION DEVICE 05/04/1990
K983438 DOREA, INC. MAX IT 02/08/1999
K896357 DR. JOHN P. MARCH SAFE AID DEVICE "IMPOTENCE DEVICE" 04/25/1990
K904406 EER, INC. EER ERECTION ENHANCED RESPONDER 02/25/1991
K864833 EKC, INC. POS-T-VAC 04/10/1987
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
K914557 GROMEDCO ECONOAID 01/23/1992
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
K881008 KENNETH CHAPMAN MAXERECT 10/12/1988
K860698 KNAPPS CORP. THE BOOSTER 02/03/1989
K882531 L.J. FANT & CO. MODIFIED L.J.'S SEX HELPER 12/08/1988
K955856 LABORIE MEDICAL TECHNOLOGIES, LTD. TEX-AID BLUE 02/16/1996
K861468 LEHIGH GROUP IMPAX, MALE IMPOTENCE AID 06/18/1986
K832543 MACE'S SCIENTIFIC MALE THERAPEUTIC POTENT AID 12/27/1983
K971257 MCKENNA & CUNEO VTU-1 VACUUM ERECTION SYSTEM 10/03/1997
K901223 MISSION PHARMACAL CO. VACUUM ERECTION DEVICE (VED) 05/04/1990
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
K993909 NANMA MFG CO., LTD. NANMA VACUUM PUMP 07/19/2000
K030913 NANMA MFG CO., LTD. NANMA VACUUM PUMP 06/03/2003
K041573 NANMA MFG CO., LTD. NANMA VACUUM PUMP PROXZEK MODEL 2M9498S 08/25/2004
K841257 NU-POTENT STA-POTENT SYSTEM 05/02/1984
K904486 NUMEDTEC, INC. SUPPORT PUMP 12/14/1990
K904485 NUMEDTEC, INC. SUPPORT RING 12/14/1990
K912736 OSBON MEDICAL SYSTEMS, LTD. ERECAID(R) SYSTEM PLUS 08/12/1991
K901318 OSBON MEDICAL SYSTEMS, LTD. STAYEREC SYSTEM(TM) 05/04/1990
K896060 PERFORMANCE MEDICAL, INC. ERECTION INDUCER DEVICE (EID) 03/20/1990
K974082 PERFORMANCE PLUS, INC. THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE 02/27/1998
K891125 PERFORMANCE, INC. CONSTRICTOR RING FOR PENILE ERECTION 04/27/1989
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
K941087 POS-T-VAC, INC. POS-T-VAC-AVP-1000 07/25/1994
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
K844445 REVIVE SYSTEMS CORP. REVIVE SYSTEM 09/17/1985
K900559 SMITH-COLLINS PHARMACEUTICAL, INC. RESPONSE EXTERNAL PENILE RIGIDITY DEVICE 05/02/1990
K993142 SOMA BLUE, INC. ELITE CUSTOM 12/27/1999
K993143 SOMA BLUE, INC. VITALITY SYSTEM 12/27/1999
K905015 SURGITEK SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE 12/28/1990
K832756 TRANS TEXAS MEDICAL DEVICES CORP. PRI A PUS 11/28/1983
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
K902240 VETCO, INC. VET (VACUUM ERECTION TECHNOLOGY) 10/12/1990
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
K940995 WALLING MEDICAL EQUIPMENT CO. RELIANT CONSTRICTION RING 06/14/1994
K980752 WALLING MEDICAL EQUIPMENT CO. XTEND 05/06/1998


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