Product code LKY
- Device name
- Device, External Penile Rigidity
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5020
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041573 | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S | Nanma Mfg Co., Ltd. | 2004-08-25 |
| K032776 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | 2003-10-03 |
| K030119 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2003-08-06 |
| K030913 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2003-06-03 |
| K013113 | MODIFICATION TO NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2002-12-20 |
| K013051 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2002-08-22 |
| K020969 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | 2002-06-05 |
| K013053 | MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2002-05-09 |
| K020154 | VT-1 | Pos-T-Vac, Inc. | 2002-04-04 |
| K020258 | SUPPORT SLEEVE | Pos-T-Vac, Inc. | 2002-04-04 |
| K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM | Endocare, Inc. | 2002-02-05 |
| K012639 | SE-300 VACUUM THERAPY SYSTEM | Vts, Inc. | 2001-11-09 |
| K012662 | SE-100 VACUUM ERECTION DEVICE | Vts, Inc. | 2001-11-09 |
| K012670 | BOSS 2000-3 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | 2001-11-09 |
| K012672 | BOSS-2000-2 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | 2001-11-09 |
| K012620 | SE-200 | Vts, Inc. | 2001-11-09 |
| K012619 | VT-1 | Vts, Inc. | 2001-11-09 |
| K001859 | PENILE CONSTRICTOR RING | Basic Solutions, LLC | 2001-01-11 |
| K003115 | ACTIS ADJUSTABLE CONSTRICTION LOOP | Vivus, Inc. | 2000-12-19 |
| K000730 | IMPOAID | Impoaid, Inc. | 2000-10-19 |
| K993909 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2000-07-19 |
| K000124 | SENSATION -VACUUM ASSIST DEVICES | Prosurg, Inc. | 2000-07-10 |
| K993343 | ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS | Erecxel Enterprises | 2000-03-20 |
| K993908 | NANMA AJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2000-01-31 |
| K993906 | NANMA NON-ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2000-01-31 |
| K993142 | ELITE CUSTOM | Soma Blue, Inc. | 1999-12-27 |
| K993143 | VITALITY SYSTEM | Soma Blue, Inc. | 1999-12-27 |
| K992442 | V.T.S., INC. (V.T.-3) | Vts, Inc. | 1999-10-05 |
| K990008 | ERCO-RIBBON -C | Ercons, Inc. | 1999-02-24 |
| K990006 | ERCO-VAC -C | Ercons, Inc. | 1999-02-24 |
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| 00850076064204 | Pump Worx Max-Width Penis Enlarger - Clear/Black | PD Products, LLC | 2026-05-01 |
| 00850076064198 | Pump Worx Pistol-Grip Power Pump - Clear/Black | PD Products, LLC | 2026-05-01 |
| 00850076064181 | Pump Worx Beginner's Power Pump - Smoke/Black | PD Products, LLC | 2026-05-01 |
| 00850076064174 | Classix Vibrating Power Pump - Clear | PD Products, LLC | 2026-05-01 |
| 00850076064167 | Pump Worx Beginner's Power Pump - Red | PD Products, LLC | 2026-05-01 |
| 00850076064150 | Classix Power Pump | PD Products, LLC | 2026-05-01 |
| 00850076064143 | Pump Worx Beginner's Power Pump - Clear | PD Products, LLC | 2026-05-01 |
| 00850076064136 | Pump Worx Beginner's Power Pump - Purple | PD Products, LLC | 2026-05-01 |
| 00850076064129 | Pump Worx Silicone Power Pump - Clear/Black | PD Products, LLC | 2026-05-01 |
| 00850076064112 | Pump Worx Silicone Power Pump - Blue | PD Products, LLC | 2026-05-01 |
| 00850076064105 | Pump Worx Max Boost - Blue | PD Products, LLC | 2026-05-01 |
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| 00850076064082 | Pump Worx Accu-Meter Power Pump - Clear/Black | PD Products, LLC | 2026-05-01 |
| 00850076064068 | Pump Worx Beginner's Vibrating Pump - Clear/Black | PD Products, LLC | 2026-05-01 |
| 00850076064051 | Pipedream Beginner's Power Pump - Blue | PD Products, LLC | 2026-05-01 |
| 00850076064044 | Pump Worx Max Boost - Black | PD Products, LLC | 2026-05-01 |
| 00850076064037 | Pipedream Beginner's Power Pump - Black | PD Products, LLC | 2026-05-01 |
| 00850076064020 | Max Boost Pro Flow - Blue/Clear | PD Products, LLC | 2026-05-01 |
| 00850076064013 | Pump Worx Max Boost - White | PD Products, LLC | 2026-05-01 |
| 00850076064006 | Pump Worx Beginner's Power Pump - Blue | PD Products, LLC | 2026-05-01 |
| 10850358007407 | Encore | ENCORE, INC. | 2019-02-18 |
| 10850358007421 | Encore | ENCORE, INC. | 2019-02-18 |
| 10850358007414 | Encore | ENCORE, INC. | 2019-02-18 |
| 99067981957529 | DUREX Play Prolong & Play | RB Health (us) LLC | 2016-09-20 |
| 00384702207012 | Rapport | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |
| 00384702206015 | Rapport | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |
| 00384702204011 | Rapport | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |
| 00384702203014 | Rapport | OWEN MUMFORD USA INCORPORATED | 2016-09-19 |