FDA Product Code
FDA Product Code LKY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5020
510(k) Clearances — 87 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K041573 | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S | Nanma Mfg Co., Ltd. | 2004-08-25 | Traditional | PDF ↗ |
| K032776 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | 2003-10-03 | Traditional | PDF ↗ |
| K030119 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2003-08-06 | Traditional | PDF ↗ |
| K030913 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2003-06-03 | Traditional | PDF ↗ |
| K013113 | MODIFICATION TO NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2002-12-20 | Traditional | PDF ↗ |
| K013051 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2002-08-22 | Traditional | PDF ↗ |
| K020969 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | 2002-06-05 | Traditional | PDF ↗ |
| K013053 | MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2002-05-09 | Traditional | PDF ↗ |
| K020258 | SUPPORT SLEEVE | Pos-T-Vac, Inc. | 2002-04-04 | Traditional | PDF ↗ |
| K020154 | VT-1 | Pos-T-Vac, Inc. | 2002-04-04 | Traditional | PDF ↗ |
| K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM | Endocare, Inc. | 2002-02-05 | Special | PDF ↗ |
| K012670 | BOSS 2000-3 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | 2001-11-09 | Traditional | PDF ↗ |
| K012620 | SE-200 | Vts, Inc. | 2001-11-09 | Traditional | PDF ↗ |
| K012639 | SE-300 VACUUM THERAPY SYSTEM | Vts, Inc. | 2001-11-09 | Traditional | PDF ↗ |
| K012619 | VT-1 | Vts, Inc. | 2001-11-09 | Traditional | PDF ↗ |
| K012662 | SE-100 VACUUM ERECTION DEVICE | Vts, Inc. | 2001-11-09 | Traditional | PDF ↗ |
| K012672 | BOSS-2000-2 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | 2001-11-09 | Traditional | PDF ↗ |
| K001859 | PENILE CONSTRICTOR RING | Basic Solutions, LLC | 2001-01-11 | Traditional | PDF ↗ |
| K003115 | ACTIS ADJUSTABLE CONSTRICTION LOOP | Vivus, Inc. | 2000-12-19 | Traditional | PDF ↗ |
| K000730 | IMPOAID | Impoaid, Inc. | 2000-10-19 | Traditional | PDF ↗ |
| K993909 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2000-07-19 | Traditional | PDF ↗ |
| K000124 | SENSATION -VACUUM ASSIST DEVICES | Prosurg, Inc. | 2000-07-10 | Traditional | PDF ↗ |
| K993343 | ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS | Erecxel Enterprises | 2000-03-20 | Traditional | PDF ↗ |
| K993908 | NANMA AJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2000-01-31 | Traditional | PDF ↗ |
| K993906 | NANMA NON-ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2000-01-31 | Traditional | PDF ↗ |
| K993143 | VITALITY SYSTEM | Soma Blue, Inc. | 1999-12-27 | Traditional | PDF ↗ |
| K993142 | ELITE CUSTOM | Soma Blue, Inc. | 1999-12-27 | Traditional | PDF ↗ |
| K992442 | V.T.S., INC. (V.T.-3) | Vts, Inc. | 1999-10-05 | Traditional | PDF ↗ |
| K990008 | ERCO-RIBBON -C | Ercons, Inc. | 1999-02-24 | Traditional | PDF ↗ |
| K990006 | ERCO-VAC -C | Ercons, Inc. | 1999-02-24 | Traditional | PDF ↗ |
| K983438 | MAX IT | Dorea, Inc. | 1999-02-08 | Traditional | PDF ↗ |
| K982275 | RAPPORT V.T.D. | Owen Mumford USA, Inc. | 1998-12-04 | Traditional | PDF ↗ |
| K981357 | ERCO-VAC | Ercons, Inc. | 1998-11-24 | Traditional | PDF ↗ |
| K981343 | ERCO-RIBBON | Ercons, Inc. | 1998-11-24 | Traditional | PDF ↗ |
| K983245 | POS-T-VAC (AVP-1000) | Pos-T-Vac, Inc. | 1998-11-02 | Traditional | PDF ↗ |
| K983246 | POS-T-VAC (IVP-600) | Pos-T-Vac, Inc. | 1998-11-02 | Traditional | PDF ↗ |
| K981011 | POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) | Pos-T-Vac, Inc. | 1998-08-28 | Traditional | PDF ↗ |
| 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. | 1998-08-28 | Traditional | PDF ↗ |
| K980948 | VED VALU- VACUUM ERECTION DEVICE | Mission Pharmacal Comp | 1998-06-25 | Traditional | PDF ↗ |
| K981506 | RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) | Repro-Med Systems, Inc. | 1998-06-25 | Traditional | PDF ↗ |
| K974196 | MEGAVAC SYSTEM | Barry J. Kaplan, Inc. | 1998-05-12 | Traditional | PDF ↗ |
| K980567 | CHARGER (ED) | Walling Medical Equipment Co. | 1998-05-06 | Traditional | PDF ↗ |
| K980752 | XTEND | Walling Medical Equipment Co. | 1998-05-06 | Traditional | PDF ↗ |
| K980291 | IMPOWER EXTERNAL VACUUM SYSTEM | Imagyn Medical Technologies, Inc. | 1998-03-11 | Traditional | PDF ↗ |
| K974082 | THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE | Performance Plus, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K974173 | ERECAID SYSTEM/STAY EREC SYSTEM | Imagyn Medical Technologies, Inc. | 1998-02-25 | Traditional | PDF ↗ |
| K974215 | VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET | Vetco, Inc. | 1998-02-19 | Traditional | PDF ↗ |
| K974470 | VTU-E VACUUM ERECTION SYSTEM | Encore, Inc. | 1998-01-09 | Traditional | PDF ↗ |
| K972537 | ERCO-VAC | Ercons, Inc. | 1997-11-03 | Traditional | PDF ↗ |
| K972353 | ERCO-RIBBON | Ercons, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K971576 | REJOYN PENILE SUPPORT SYSTEM | American Medtech | 1997-10-16 | Traditional | PDF ↗ |
| K971257 | VTU-1 VACUUM ERECTION SYSTEM | Mckenna & Cuneo | 1997-10-03 | Traditional | PDF ↗ |
| K971768 | RELIANT CHARGER | Walling Medical Equipment Co. | 1997-09-29 | Traditional | PDF ↗ |
| K971443 | RAPPORT V.T.D. | Owen Mumford USA, Inc. | 1997-09-26 | Traditional | PDF ↗ |
| K962915 | ACTIS (VENOUS FLOW CONTROLLER) | Vivus, Inc. | 1996-12-10 | Traditional | PDF ↗ |
| K960828 | POS-T-VAC B-10 BAND KIT | Pos-T-Vac, Inc. | 1996-03-08 | Traditional | PDF ↗ |
| K960342 | POS-T-VAC AVP-1000 & MVP-700 | Pos-T-Vac, Inc. | 1996-03-01 | Traditional | PDF ↗ |
| K955856 | TEX-AID BLUE | Laborie Medical Technologies, Ltd. | 1996-02-16 | Traditional | PDF ↗ |
| K941087 | POS-T-VAC-AVP-1000 | Pos-T-Vac, Inc. | 1994-07-25 | Traditional | PDF ↗ |
| K940995 | RELIANT CONSTRICTION RING | Walling Medical Equipment Co. | 1994-06-14 | Traditional | PDF ↗ |
| K932397 | RELIANT | Allan Walling Medical Equipment Co. | 1994-03-07 | Traditional | PDF ↗ |
| K920409 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE | Dacomed Corp. | 1992-05-11 | Traditional | PDF ↗ |
| K914557 | ECONOAID | Gromedco | 1992-01-23 | Traditional | PDF ↗ |
| K912736 | ERECAID(R) SYSTEM PLUS | Osbon Medical Systems, Ltd. | 1991-08-12 | Traditional | PDF ↗ |
| K904406 | EER ERECTION ENHANCED RESPONDER | Eer, Inc. | 1991-02-25 | Traditional | PDF ↗ |
| K905195 | FIRM MASTER | Bak Medical Products | 1991-02-01 | Traditional | PDF ↗ |
| K905015 | SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE | Surgitek | 1990-12-28 | Traditional | PDF ↗ |
| K904486 | SUPPORT PUMP | Numedtec, Inc. | 1990-12-14 | Traditional | PDF ↗ |
| K904485 | SUPPORT RING | Numedtec, Inc. | 1990-12-14 | Traditional | PDF ↗ |
| K902240 | VET (VACUUM ERECTION TECHNOLOGY) | Vetco, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K901318 | STAYEREC SYSTEM(TM) | Osbon Medical Systems, Ltd. | 1990-05-04 | Traditional | PDF ↗ |
| K901223 | VACUUM ERECTION DEVICE (VED) | Mission Pharmacal Co. | 1990-05-04 | Traditional | PDF ↗ |
| K900774 | DACOMED NEGATIVE PRESSURE ERECTION DEVICE | Dacomed Corp. | 1990-05-04 | Traditional | PDF ↗ |
| K900559 | RESPONSE EXTERNAL PENILE RIGIDITY DEVICE | Smith-Collins Pharmaceutical, Inc. | 1990-05-02 | Traditional | PDF ↗ |
| K896357 | SAFE AID DEVICE IMPOTENCE DEVICE | Dr. John P. March | 1990-04-25 | Traditional | PDF ↗ |
| K896060 | ERECTION INDUCER DEVICE (EID) | Performance Medical, Inc. | 1990-03-20 | Traditional | PDF ↗ |
| K896061 | ERECTION DEVICE | Clyde Engineering Service | 1990-03-07 | Traditional | PDF ↗ |
| K891125 | CONSTRICTOR RING FOR PENILE ERECTION | Performance, Inc. | 1989-04-27 | Traditional | PDF ↗ |
| K860698 | THE BOOSTER | Knapps Corp. | 1989-02-03 | Traditional | PDF ↗ |
| K882531 | MODIFIED L.J.'S SEX HELPER | L.J. Fant & Co. | 1988-12-08 | Traditional | PDF ↗ |
| K881008 | MAXERECT | Kenneth Chapman | 1988-10-12 | Traditional | PDF ↗ |
| K864833 | POS-T-VAC | Ekc, Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K861468 | IMPAX, MALE IMPOTENCE AID | Lehigh Group | 1986-06-18 | Traditional | PDF ↗ |
| K844445 | REVIVE SYSTEM | Revive Systems Corp. | 1985-09-17 | Traditional | PDF ↗ |
| K841257 | STA-POTENT SYSTEM | Nu-Potent | 1984-05-02 | Traditional | PDF ↗ |
| K832543 | MALE THERAPEUTIC POTENT AID | Mace'S Scientific | 1983-12-27 | Traditional | PDF ↗ |
| K832756 | PRI A PUS | Trans Texas Medical Devices Corp. | 1983-11-28 | Traditional | PDF ↗ |
Product code LKY · Class II · Gastroenterology, Urology. Data: openFDA.