Product Code: LKY FDA class 2 21 CFR 876.5020

Device, External Penile Rigidity

Gastroenterology, Urology

Device, External Penile Rigidity is intended to create or maintain sufficient penile rigidity for sexual intercourse; these devices include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered, or pneumatic devices. It is classified as FDA Class 2, indicating moderate risk, subject to general controls and special controls. The product code is LKY, regulated under 21 CFR 876.5020, within the Gastroenterology/Urology medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: LKY
Device Class: FDA class 2
Regulation Number: 876.5020
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 87 510(k) clearances via K numbers.

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