LKY · Device, External Penile Rigidity
Gastroenterology, Urology · 21 CFR 876.5020 · Class 2
Overview
| Product Code | LKY |
|---|---|
| Device Name | Device, External Penile Rigidity |
| Regulation | 21 CFR 876.5020 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.
Classification Rationale
Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.
Cleared Devices (87)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K041573 | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S | Nanma Mfg Co., Ltd. | Aug 25, 2004 | SESE |
| K032776 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | Oct 3, 2003 | SESE |
| K030119 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | Aug 6, 2003 | SESE |
| K030913 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | Jun 3, 2003 | SESE |
| K013113 | MODIFICATION TO NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | Dec 20, 2002 | SESE |
| K013051 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | Aug 22, 2002 | SESE |
| K020969 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | Jun 5, 2002 | SESE |
| K013053 | MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | May 9, 2002 | SESE |
| K020258 | SUPPORT SLEEVE | Pos-T-Vac, Inc. | Apr 4, 2002 | SESE |
| K020154 | VT-1 | Pos-T-Vac, Inc. | Apr 4, 2002 | SESE |
| K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM | Endocare, Inc. | Feb 5, 2002 | SESE |
| K012672 | BOSS-2000-2 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | Nov 9, 2001 | SESE |
| K012670 | BOSS 2000-3 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | Nov 9, 2001 | SESE |
| K012662 | SE-100 VACUUM ERECTION DEVICE | Vts, Inc. | Nov 9, 2001 | SESE |
| K012639 | SE-300 VACUUM THERAPY SYSTEM | Vts, Inc. | Nov 9, 2001 | SESE |
| K012620 | SE-200 | Vts, Inc. | Nov 9, 2001 | SESE |
| K012619 | VT-1 | Vts, Inc. | Nov 9, 2001 | SESE |
| K001859 | PENILE CONSTRICTOR RING | Basic Solutions, LLC | Jan 11, 2001 | SESE |
| K003115 | ACTIS ADJUSTABLE CONSTRICTION LOOP | Vivus, Inc. | Dec 19, 2000 | SESE |
| K000730 | IMPOAID | Impoaid, Inc. | Oct 19, 2000 | SESE |
| K993909 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | Jul 19, 2000 | SESE |
| K000124 | SENSATION -VACUUM ASSIST DEVICES | Prosurg, Inc. | Jul 10, 2000 | SESE |
| K993343 | ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS | Erecxel Enterprises | Mar 20, 2000 | SESE |
| K993908 | NANMA AJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | Jan 31, 2000 | SESE |
| K993906 | NANMA NON-ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | Jan 31, 2000 | SESE |
| K993143 | VITALITY SYSTEM | Soma Blue, Inc. | Dec 27, 1999 | SESE |
| K993142 | ELITE CUSTOM | Soma Blue, Inc. | Dec 27, 1999 | SESE |
| K992442 | V.T.S., INC. (V.T.-3) | Vts, Inc. | Oct 5, 1999 | SESE |
| K990008 | ERCO-RIBBON -C | Ercons, Inc. | Feb 24, 1999 | SESE |
| K990006 | ERCO-VAC -C | Ercons, Inc. | Feb 24, 1999 | SESE |
| K983438 | MAX IT | Dorea, Inc. | Feb 8, 1999 | SESE |
| K982275 | RAPPORT V.T.D. | Owen Mumford USA, Inc. | Dec 4, 1998 | SESE |
| K981357 | ERCO-VAC | Ercons, Inc. | Nov 24, 1998 | SESE |
| K981343 | ERCO-RIBBON | Ercons, Inc. | Nov 24, 1998 | SESE |
| K983246 | POS-T-VAC (IVP-600) | Pos-T-Vac, Inc. | Nov 2, 1998 | SESE |
| K983245 | POS-T-VAC (AVP-1000) | Pos-T-Vac, Inc. | Nov 2, 1998 | SESE |
| 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. | Aug 28, 1998 | SESE |
| K981011 | POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) | Pos-T-Vac, Inc. | Aug 28, 1998 | SESE |
| K981506 | RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) | Repro-Med Systems, Inc. | Jun 25, 1998 | SESE |
| K980948 | VED VALU- VACUUM ERECTION DEVICE | Mission Pharmacal Comp | Jun 25, 1998 | SESE |
| K974196 | MEGAVAC SYSTEM | Barry J. Kaplan, Inc. | May 12, 1998 | SESE |
| K980752 | XTEND | Walling Medical Equipment Co. | May 6, 1998 | SESE |
| K980567 | CHARGER (ED) | Walling Medical Equipment Co. | May 6, 1998 | SESE |
| K980291 | IMPOWER EXTERNAL VACUUM SYSTEM | Imagyn Medical Technologies, Inc. | Mar 11, 1998 | SESE |
| K974082 | THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE | Performance Plus, Inc. | Feb 27, 1998 | SESE |
| K974173 | ERECAID SYSTEM/STAY EREC SYSTEM | Imagyn Medical Technologies, Inc. | Feb 25, 1998 | SESE |
| K974215 | VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET | Vetco, Inc. | Feb 19, 1998 | SESE |
| K974470 | VTU-E VACUUM ERECTION SYSTEM | Encore, Inc. | Jan 9, 1998 | SESE |
| K972537 | ERCO-VAC | Ercons, Inc. | Nov 3, 1997 | SESE |
| K972353 | ERCO-RIBBON | Ercons, Inc. | Oct 28, 1997 | SESE |
| K971576 | REJOYN PENILE SUPPORT SYSTEM | American Medtech | Oct 16, 1997 | SESE |
| K971257 | VTU-1 VACUUM ERECTION SYSTEM | Mckenna & Cuneo | Oct 3, 1997 | SESE |
| K971768 | RELIANT CHARGER | Walling Medical Equipment Co. | Sep 29, 1997 | SESE |
| K971443 | RAPPORT V.T.D. | Owen Mumford USA, Inc. | Sep 26, 1997 | SESE |
| K962915 | ACTIS (VENOUS FLOW CONTROLLER) | Vivus, Inc. | Dec 10, 1996 | SESE |
| K960828 | POS-T-VAC B-10 BAND KIT | Pos-T-Vac, Inc. | Mar 8, 1996 | SESE |
| K960342 | POS-T-VAC AVP-1000 & MVP-700 | Pos-T-Vac, Inc. | Mar 1, 1996 | SESE |
| K955856 | TEX-AID BLUE | Laborie Medical Technologies, Ltd. | Feb 16, 1996 | SESE |
| K941087 | POS-T-VAC-AVP-1000 | Pos-T-Vac, Inc. | Jul 25, 1994 | SESE |
| K940995 | RELIANT CONSTRICTION RING | Walling Medical Equipment Co. | Jun 14, 1994 | SESE |
| K932397 | RELIANT | Allan Walling Medical Equipment Co. | Mar 7, 1994 | SESE |
| K920409 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE | Dacomed Corp. | May 11, 1992 | SESE |
| K914557 | ECONOAID | Gromedco | Jan 23, 1992 | SESE |
| K912736 | ERECAID(R) SYSTEM PLUS | Osbon Medical Systems, Ltd. | Aug 12, 1991 | SESE |
| K904406 | EER ERECTION ENHANCED RESPONDER | Eer, Inc. | Feb 25, 1991 | SESE |
| K905195 | FIRM MASTER | Bak Medical Products | Feb 1, 1991 | SESE |
| K905015 | SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE | Surgitek | Dec 28, 1990 | SESE |
| K904486 | SUPPORT PUMP | Numedtec, Inc. | Dec 14, 1990 | SESE |
| K904485 | SUPPORT RING | Numedtec, Inc. | Dec 14, 1990 | SESE |
| K902240 | VET (VACUUM ERECTION TECHNOLOGY) | Vetco, Inc. | Oct 12, 1990 | SESE |
| K901318 | STAYEREC SYSTEM(TM) | Osbon Medical Systems, Ltd. | May 4, 1990 | SESE |
| K901223 | VACUUM ERECTION DEVICE (VED) | Mission Pharmacal Co. | May 4, 1990 | SESE |
| K900774 | DACOMED NEGATIVE PRESSURE ERECTION DEVICE | Dacomed Corp. | May 4, 1990 | SESE |
| K900559 | RESPONSE EXTERNAL PENILE RIGIDITY DEVICE | Smith-Collins Pharmaceutical, Inc. | May 2, 1990 | SESE |
| K896357 | SAFE AID DEVICE IMPOTENCE DEVICE | Dr. John P. March | Apr 25, 1990 | SESE |
| K896060 | ERECTION INDUCER DEVICE (EID) | Performance Medical, Inc. | Mar 20, 1990 | SESE |
| K896061 | ERECTION DEVICE | Clyde Engineering Service | Mar 7, 1990 | SESE |
| K891125 | CONSTRICTOR RING FOR PENILE ERECTION | Performance, Inc. | Apr 27, 1989 | SESE |
| K860698 | THE BOOSTER | Knapps Corp. | Feb 3, 1989 | SESE |
| K882531 | MODIFIED L.J.'S SEX HELPER | L.J. Fant & Co. | Dec 8, 1988 | SESE |
| K881008 | MAXERECT | Kenneth Chapman | Oct 12, 1988 | SESE |
| K864833 | POS-T-VAC | Ekc, Inc. | Apr 10, 1987 | SESE |
| K861468 | IMPAX, MALE IMPOTENCE AID | Lehigh Group | Jun 18, 1986 | SESE |
| K844445 | REVIVE SYSTEM | Revive Systems Corp. | Sep 17, 1985 | SESE |
| K841257 | STA-POTENT SYSTEM | Nu-Potent | May 2, 1984 | SESE |
| K832543 | MALE THERAPEUTIC POTENT AID | Mace'S Scientific | Dec 27, 1983 | SESE |
| K832756 | PRI A PUS | Trans Texas Medical Devices Corp. | Nov 28, 1983 | SESE |
Top Applicants
- Pos-T-Vac, Inc. — 11 clearances
- Nanma Mfg Co., Ltd. — 9 clearances
- Ercons, Inc. — 6 clearances
- Vts, Inc. — 5 clearances
- Walling Medical Equipment Co. — 4 clearances
