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 |
|---|---|---|---|
| Oct 16, 1997 | K971576 | REJOYN PENILE SUPPORT SYSTEM American Medtech | LKY |
| Oct 3, 1997 | K971257 | VTU-1 VACUUM ERECTION SYSTEM Mckenna & Cuneo | LKY |
| Sep 29, 1997 | K971768 | RELIANT CHARGER Walling Medical Equipment Co. | LKY |
| Sep 26, 1997 | K971443 | RAPPORT V.T.D. Owen Mumford USA, Inc. | LKY |
| Dec 10, 1996 | K962915 | ACTIS (VENOUS FLOW CONTROLLER) Vivus, Inc. | LKY |
| Mar 8, 1996 | K960828 | POS-T-VAC B-10 BAND KIT Pos-T-Vac, Inc. | LKY |
| Mar 1, 1996 | K960342 | POS-T-VAC AVP-1000 & MVP-700 Pos-T-Vac, Inc. | LKY |
| Feb 16, 1996 | K955856 | TEX-AID BLUE Laborie Medical Technologies, Ltd., CA | LKY |
| Jul 25, 1994 | K941087 | POS-T-VAC-AVP-1000 Pos-T-Vac, Inc. | LKY |
| Jun 14, 1994 | K940995 | RELIANT CONSTRICTION RING Walling Medical Equipment Co. | LKY |
| Mar 7, 1994 | K932397 | RELIANT Allan Walling Medical Equipment Co. | LKY |
| May 11, 1992 | K920409 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE Dacomed Corp. | LKY |
| Jan 23, 1992 | K914557 | ECONOAID Gromedco | LKY |
| Aug 12, 1991 | K912736 | ERECAID(R) SYSTEM PLUS Osbon Medical Systems, Ltd. | LKY |
| Feb 25, 1991 | K904406 | EER ERECTION ENHANCED RESPONDER Eer, Inc. | LKY |
| Feb 1, 1991 | K905195 | FIRM MASTER Bak Medical Products | LKY |
| Dec 28, 1990 | K905015 | SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE Surgitek | LKY |
| Dec 14, 1990 | K904486 | SUPPORT PUMP Numedtec, Inc. | LKY |
| Dec 14, 1990 | K904485 | SUPPORT RING Numedtec, Inc. | LKY |
| Oct 12, 1990 | K902240 | VET (VACUUM ERECTION TECHNOLOGY) Vetco, Inc. | LKY |
| May 4, 1990 | K901318 | STAYEREC SYSTEM(TM) Osbon Medical Systems, Ltd. | LKY |
| May 4, 1990 | K901223 | VACUUM ERECTION DEVICE (VED) Mission Pharmacal Co. | LKY |
| May 4, 1990 | K900774 | DACOMED NEGATIVE PRESSURE ERECTION DEVICE Dacomed Corp. | LKY |
| May 2, 1990 | K900559 | RESPONSE EXTERNAL PENILE RIGIDITY DEVICE Smith-Collins Pharmaceutical, Inc. | LKY |
| Apr 25, 1990 | K896357 | SAFE AID DEVICE IMPOTENCE DEVICE Dr. John P. March | LKY |
| Mar 20, 1990 | K896060 | ERECTION INDUCER DEVICE (EID) Performance Medical, Inc. | LKY |
| Mar 7, 1990 | K896061 | ERECTION DEVICE Clyde Engineering Service | LKY |
| Apr 27, 1989 | K891125 | CONSTRICTOR RING FOR PENILE ERECTION Performance, Inc. | LKY |
| Feb 3, 1989 | K860698 | THE BOOSTER Knapps Corp. | LKY |
| Dec 8, 1988 | K882531 | MODIFIED L.J.'S SEX HELPER L.J. Fant & Co. | LKY |
| Oct 12, 1988 | K881008 | MAXERECT Kenneth Chapman | LKY |
| Apr 10, 1987 | K864833 | POS-T-VAC Ekc, Inc. | LKY |
| Jun 18, 1986 | K861468 | IMPAX, MALE IMPOTENCE AID Lehigh Group | LKY |
| Sep 17, 1985 | K844445 | REVIVE SYSTEM Revive Systems Corp. | LKY |
| May 2, 1984 | K841257 | STA-POTENT SYSTEM Nu-Potent | LKY |
| Dec 27, 1983 | K832543 | MALE THERAPEUTIC POTENT AID Mace'S Scientific | LKY |
| Nov 28, 1983 | K832756 | PRI A PUS Trans Texas Medical Devices Corp. | LKY |
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