Device, External Penile Rigidity

FDA product code LKY · 87 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5020
Review panel: GU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1983-11-28 – 2004-08-25

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.

LKY 2004-08-25

NANMA VACUUM PUMP PROXZEK MODEL 2M9498S

Applicant Nanma Mfg Co., Ltd.

K number K041573

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LKY 2003-10-03

VACURECT VACUUM CONSTRICTION DEVICE

Applicant Vacurect Manufacturing (Pty) , Ltd.

K number K032776

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LKY 2003-08-06

NANMA ADJUSTABLE CONSTRICTION RING

Applicant Nanma Mfg Co., Ltd.

K number K030119

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LKY 2003-06-03

NANMA VACUUM PUMP

Applicant Nanma Mfg Co., Ltd.

K number K030913

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LKY 2002-12-20

MODIFICATION TO NANMA VACUUM PUMP

Applicant Nanma Mfg Co., Ltd.

K number K013113

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LKY 2002-08-22

NANMA ADJUSTABLE CONSTRICTION RING

Applicant Nanma Mfg Co., Ltd.

K number K013051

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LKY 2002-06-05

VACURECT VACUUM CONSTRICTION DEVICE

Applicant Vacurect Manufacturing (Pty) , Ltd.

K number K020969

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LKY 2002-05-09

MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING

Applicant Nanma Mfg Co., Ltd.

K number K013053

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LKY 2002-04-04

SUPPORT SLEEVE

Applicant Pos-T-Vac, Inc.

K number K020258

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LKY 2002-04-04

VT-1

Applicant Pos-T-Vac, Inc.

K number K020154

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LKY 2002-02-05

ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM

Applicant Endocare, Inc.

K number K020082

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LKY 2001-11-09

BOSS-2000-2 VACUUM ERECTION DEVICE

Applicant Pos-T-Vac, Inc.

K number K012672

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LKY 2001-11-09

BOSS 2000-3 VACUUM ERECTION DEVICE

Applicant Pos-T-Vac, Inc.

K number K012670

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LKY 2001-11-09

SE-100 VACUUM ERECTION DEVICE

Applicant Vts, Inc.

K number K012662

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LKY 2001-11-09

SE-300 VACUUM THERAPY SYSTEM

Applicant Vts, Inc.

K number K012639

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LKY 2001-11-09

SE-200

Applicant Vts, Inc.

K number K012620

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LKY 2001-11-09

VT-1

Applicant Vts, Inc.

K number K012619

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LKY 2001-01-11

PENILE CONSTRICTOR RING

Applicant Basic Solutions, LLC

K number K001859

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LKY 2000-12-19

ACTIS ADJUSTABLE CONSTRICTION LOOP

Applicant Vivus, Inc.

K number K003115

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LKY 2000-10-19

IMPOAID

Applicant Impoaid, Inc.

K number K000730

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LKY 2000-07-19

NANMA VACUUM PUMP

Applicant Nanma Mfg Co., Ltd.

K number K993909

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LKY 2000-07-10

SENSATION -VACUUM ASSIST DEVICES

Applicant Prosurg, Inc.

K number K000124

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LKY 2000-03-20

ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS

Applicant Erecxel Enterprises

K number K993343

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LKY 2000-01-31

NANMA AJUSTABLE CONSTRICTION RING

Applicant Nanma Mfg Co., Ltd.

K number K993908

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LKY 2000-01-31

NANMA NON-ADJUSTABLE CONSTRICTION RING

Applicant Nanma Mfg Co., Ltd.

K number K993906

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LKY 1999-12-27

VITALITY SYSTEM

Applicant Soma Blue, Inc.

K number K993143

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LKY 1999-12-27

ELITE CUSTOM

Applicant Soma Blue, Inc.

K number K993142

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LKY 1999-10-05

V.T.S., INC. (V.T.-3)

Applicant Vts, Inc.

K number K992442

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LKY 1999-02-24

ERCO-RIBBON -C

Applicant Ercons, Inc.

K number K990008

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LKY 1999-02-24

ERCO-VAC -C

Applicant Ercons, Inc.

K number K990006

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LKY 1999-02-08

MAX IT

Applicant Dorea, Inc.

K number K983438

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LKY 1998-12-04

RAPPORT V.T.D.

Applicant Owen Mumford USA, Inc.

K number K982275

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LKY 1998-11-24

ERCO-VAC

Applicant Ercons, Inc.

K number K981357

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LKY 1998-11-24

ERCO-RIBBON

Applicant Ercons, Inc.

K number K981343

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LKY 1998-11-02

POS-T-VAC (IVP-600)

Applicant Pos-T-Vac, Inc.

K number K983246

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LKY 1998-11-02

POS-T-VAC (AVP-1000)

Applicant Pos-T-Vac, Inc.

K number K983245

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LKY 1998-08-28

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

Applicant Pos-T-Vac, Inc.

K number K981180

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LKY 1998-08-28

POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)

Applicant Pos-T-Vac, Inc.

K number K981011

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LKY 1998-06-25

RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)

Applicant Repro-Med Systems, Inc.

K number K981506

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LKY 1998-06-25

VED VALU- VACUUM ERECTION DEVICE

Applicant Mission Pharmacal Comp

K number K980948

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LKY 1998-05-12

MEGAVAC SYSTEM

Applicant Barry J. Kaplan, Inc.

K number K974196

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LKY 1998-05-06

XTEND

Applicant Walling Medical Equipment Co.

K number K980752

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LKY 1998-05-06

CHARGER (ED)

Applicant Walling Medical Equipment Co.

K number K980567

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LKY 1998-03-11

IMPOWER EXTERNAL VACUUM SYSTEM

Applicant Imagyn Medical Technologies, Inc.

K number K980291

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LKY 1998-02-27

THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE

Applicant Performance Plus, Inc.

K number K974082

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LKY 1998-02-25

ERECAID SYSTEM/STAY EREC SYSTEM

Applicant Imagyn Medical Technologies, Inc.

K number K974173

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LKY 1998-02-19

VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET

Applicant Vetco, Inc.

K number K974215

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LKY 1998-01-09

VTU-E VACUUM ERECTION SYSTEM

Applicant Encore, Inc.

K number K974470

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LKY 1997-11-03

ERCO-VAC

Applicant Ercons, Inc.

K number K972537

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LKY 1997-10-28

ERCO-RIBBON

Applicant Ercons, Inc.

K number K972353

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LKY 1997-10-16

REJOYN PENILE SUPPORT SYSTEM

Applicant American Medtech

K number K971576

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LKY 1997-10-03

VTU-1 VACUUM ERECTION SYSTEM

Applicant Mckenna & Cuneo

K number K971257

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LKY 1997-09-29

RELIANT CHARGER

Applicant Walling Medical Equipment Co.

K number K971768

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LKY 1997-09-26

RAPPORT V.T.D.

Applicant Owen Mumford USA, Inc.

K number K971443

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LKY 1996-12-10

ACTIS (VENOUS FLOW CONTROLLER)

Applicant Vivus, Inc.

K number K962915

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LKY 1996-03-08

POS-T-VAC B-10 BAND KIT

Applicant Pos-T-Vac, Inc.

K number K960828

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LKY 1996-03-01

POS-T-VAC AVP-1000 & MVP-700

Applicant Pos-T-Vac, Inc.

K number K960342

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LKY 1996-02-16

TEX-AID BLUE

Applicant Laborie Medical Technologies, Ltd.

K number K955856

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LKY 1994-07-25

POS-T-VAC-AVP-1000

Applicant Pos-T-Vac, Inc.

K number K941087

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LKY 1994-06-14

RELIANT CONSTRICTION RING

Applicant Walling Medical Equipment Co.

K number K940995

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LKY 1994-03-07

RELIANT

Applicant Allan Walling Medical Equipment Co.

K number K932397

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LKY 1992-05-11

DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE

Applicant Dacomed Corp.

K number K920409

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LKY 1992-01-23

ECONOAID

Applicant Gromedco

K number K914557

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LKY 1991-08-12

ERECAID(R) SYSTEM PLUS

Applicant Osbon Medical Systems, Ltd.

K number K912736

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LKY 1991-02-25

EER ERECTION ENHANCED RESPONDER

Applicant Eer, Inc.

K number K904406

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LKY 1991-02-01

FIRM MASTER

Applicant Bak Medical Products

K number K905195

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LKY 1990-12-28

SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE

Applicant Surgitek

K number K905015

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LKY 1990-12-14

SUPPORT PUMP

Applicant Numedtec, Inc.

K number K904486

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LKY 1990-12-14

SUPPORT RING

Applicant Numedtec, Inc.

K number K904485

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LKY 1990-10-12

VET (VACUUM ERECTION TECHNOLOGY)

Applicant Vetco, Inc.

K number K902240

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LKY 1990-05-04

STAYEREC SYSTEM(TM)

Applicant Osbon Medical Systems, Ltd.

K number K901318

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LKY 1990-05-04

VACUUM ERECTION DEVICE (VED)

Applicant Mission Pharmacal Co.

K number K901223

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LKY 1990-05-04

DACOMED NEGATIVE PRESSURE ERECTION DEVICE

Applicant Dacomed Corp.

K number K900774

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LKY 1990-05-02

RESPONSE EXTERNAL PENILE RIGIDITY DEVICE

Applicant Smith-Collins Pharmaceutical, Inc.

K number K900559

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LKY 1990-04-25

SAFE AID DEVICE IMPOTENCE DEVICE

Applicant Dr. John P. March

K number K896357

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LKY 1990-03-20

ERECTION INDUCER DEVICE (EID)

Applicant Performance Medical, Inc.

K number K896060

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LKY 1990-03-07

ERECTION DEVICE

Applicant Clyde Engineering Service

K number K896061

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LKY 1989-04-27

CONSTRICTOR RING FOR PENILE ERECTION

Applicant Performance, Inc.

K number K891125

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LKY 1989-02-03

THE BOOSTER

Applicant Knapps Corp.

K number K860698

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LKY 1988-12-08

MODIFIED L.J.'S SEX HELPER

Applicant L.J. Fant & Co.

K number K882531

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LKY 1988-10-12

MAXERECT

Applicant Kenneth Chapman

K number K881008

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LKY 1987-04-10

POS-T-VAC

Applicant Ekc, Inc.

K number K864833

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LKY 1986-06-18

IMPAX, MALE IMPOTENCE AID

Applicant Lehigh Group

K number K861468

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LKY 1985-09-17

REVIVE SYSTEM

Applicant Revive Systems Corp.

K number K844445

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LKY 1984-05-02

STA-POTENT SYSTEM

Applicant Nu-Potent

K number K841257

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LKY 1983-12-27

MALE THERAPEUTIC POTENT AID

Applicant Mace'S Scientific

K number K832543

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LKY 1983-11-28

PRI A PUS

Applicant Trans Texas Medical Devices Corp.

K number K832756

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