FDA.reportPublic FDA data

Penile vacuum device

Definition
A device that is applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is typically a two-component device consisting of: 1) a manually-operated, vacuum pump/sleeve which is applied over the flaccid penis and used to create a vacuum to achieve tumescence through an up and down movement along a vacuum tube; and 2) a constriction ring used in conjunction with the pump and placed upon the penis to maintain the erection. The ring remains on the penis for a recommended period of time. This is a reusable device.
GUDID devices
343
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00384702203014RapportOWEN MUMFORD USA INCORPORATEDSM 22032016-09-19
00384702204011Rapport OWEN MUMFORD USA INCORPORATEDSM 22042016-09-19
00384702206015Rapport OWEN MUMFORD USA INCORPORATEDSM 22062016-09-19
00384702207012Rapport OWEN MUMFORD USA INCORPORATEDSM 22072016-09-19
00850076064006Pump Worx Beginner's Power Pump - Blue PD Products, LLC3260142026-05-01
00850076064013Pump Worx Max Boost - White PD Products, LLC3249192026-05-01
00850076064020Max Boost Pro Flow - Blue/Clear PD Products, LLC3250252026-05-01
00850076064037Pipedream Beginner's Power Pump - Black PD Products, LLC3241242026-05-01
00850076064044Pump Worx Max Boost - Black PD Products, LLC3249232026-05-01
00850076064051Pipedream Beginner's Power Pump - Blue PD Products, LLC3241142026-05-01
00850076064068Pump Worx Beginner's Vibrating Pump - Clear/Black PD Products, LLC3250232026-05-01
00850076064075Max Boost Pro Flow - White/Clear PD Products, LLC3250192026-05-01
00850076064082Pump Worx Accu-Meter Power Pump - Clear/Black PD Products, LLC3272232026-05-01
00850076064099Pump Worx Rookie of the Year Pump - Clear/Black PD Products, LLC3253232026-05-01
00850076064105Pump Worx Max Boost - Blue PD Products, LLC3249252026-05-01
00850076064112Pump Worx Silicone Power Pump - Blue PD Products, LLC3255142026-05-01
00850076064129Pump Worx Silicone Power Pump - Clear/Black PD Products, LLC3255202026-05-01
00850076064136Pump Worx Beginner's Power Pump - Purple PD Products, LLC3260122026-05-01
00850076064143Pump Worx Beginner's Power Pump - Clear PD Products, LLC3260202026-05-01
00850076064150Classix Power PumpPD Products, LLC1908002026-05-01
00850076064167Pump Worx Beginner's Power Pump - Red PD Products, LLC3260152026-05-01
00850076064174Classix Vibrating Power Pump - ClearPD Products, LLC1927002026-05-01
00850076064181Pump Worx Beginner's Power Pump - Smoke/Black PD Products, LLC3260232026-05-01
00850076064198Pump Worx Pistol-Grip Power Pump - Clear/Black PD Products, LLC3266232026-05-01
00850076064204Pump Worx Max-Width Penis Enlarger - Clear/Black PD Products, LLC3262232026-05-01
00850076064211Pipedream Beginner's Power Pump - Clear PD Products, LLC3241202026-05-01
05060140200895VAXAIDDX PRODUCTS LIMITEDV3 DELUXE2023-10-01
05060140201014BathmateDX PRODUCTS LIMITEDHydromax 8 AB2023-10-01
05060140201021BathmateDX PRODUCTS LIMITEDHydromax 8 CC2023-10-01
05060140201038BathmateDX PRODUCTS LIMITEDHydromax 8 BR2023-10-01
05060140201106BathmateDX PRODUCTS LIMITEDHydroXtreme 8 2024-01-01
05060140208297BathmateDX PRODUCTS LIMITEDHydro 5 Brilliant Red2020-04-01
05060140208303BathmateDX PRODUCTS LIMITEDHydro 5 Crystal Clear2020-04-01
05060140208310BathmateDX PRODUCTS LIMITEDHydro 5 Aqua Blue2020-04-01
05060140208358BathmateDX PRODUCTS LIMITEDHydro 3 Brilliant Red2020-04-01
05060140208372BathmateDX PRODUCTS LIMITEDHydro 3 Crystal Clear2020-04-01
05060140208402BathmateDX PRODUCTS LIMITEDHydro 3 Aqua Blue2020-04-01
05060140208440VaxaidDX PRODUCTS LIMITEDVaxaid V5 Delux2019-03-01
05060140208464VaxaidDX PRODUCTS LIMITEDVaxaid V5 Trainer2019-03-01
05060140208488VaxaidDX PRODUCTS LIMITEDVaxaid V7 Delux2019-03-01
05060140208501VaxaidDX PRODUCTS LIMITEDVaxaid V7 Trainer2019-03-01
05060140208525VaxaidDX PRODUCTS LIMITEDVaxaid V9 Delux2019-03-01
05060140209201BathmateDX PRODUCTS LIMITEDHydromax 3 Brilliant Red2021-03-01
05060140209225BathmateDX PRODUCTS LIMITEDHydroxtreme 11 CC2018-03-05
05060140209249BathmateDX PRODUCTS LIMITEDHydroxtreme 9 CC2018-03-05
05060140209263BathmateDX PRODUCTS LIMITEDHydroxtreme 7 Wideboy CC2018-03-05
05060140209287BathmateDX PRODUCTS LIMITEDHydroxtreme 7 CC2018-03-05
05060140209324BathmateDX PRODUCTS LIMITEDHydroxtreme 5 CC2018-03-05
05060140209348BathmateDX PRODUCTS LIMITEDHydromax 9 BR2018-03-05
05060140209362BathmateDX PRODUCTS LIMITEDHydromax 9 CC2018-03-05
05060140209386BathmateDX PRODUCTS LIMITEDHydromax 9 AB2018-03-05
05060140209409BathmateDX PRODUCTS LIMITEDHydromax 7 Wideboy BR2018-03-05
05060140209447BathmateDX PRODUCTS LIMITEDHydromax 7 Wideboy CC2018-03-05
05060140209485BathmateDX PRODUCTS LIMITEDHydromax 7 Wideboy AB2018-03-05
05060140209522BathmateDX PRODUCTS LIMITEDHydromax 7 BR2018-03-05
05060140209560BathmateDX PRODUCTS LIMITEDHydromax 7 CC2018-03-05
05060140209607BathmateDX PRODUCTS LIMITEDHydromax 7 AB2018-03-05
05060140209768BathmateDX PRODUCTS LIMITEDHydromax 5 BR2018-03-05
05060140209805BathmateDX PRODUCTS LIMITEDHydromax 5 CC2018-03-05
05060140209843BathmateDX PRODUCTS LIMITEDHydromax 5 AB2018-03-05
05060140209881BathmateDX PRODUCTS LIMITEDHydro 7 BR2018-03-05
05060140209928BathmateDX PRODUCTS LIMITEDHydro 7 CC2018-03-05
05060140209966BathmateDX PRODUCTS LIMITEDHydro 7 AB2018-03-05
10850358007407EncoreENCORE, INC.44017 RETNP - Carton 122019-02-18
10850358007414EncoreENCORE, INC.44017 UNB - Carton 122019-02-18
10850358007421EncoreENCORE, INC.44017 UNM - Carton 122019-02-18
00850005747079Dr. Joel KaplanDr. Joel Kaplan, Inc.0904-0012025-04-14
00850005747260Dr. Joel KaplanDr. Joel Kaplan, Inc.0201-1752025-04-14
00850005747277Dr. Joel KaplanDr. Joel Kaplan, Inc.0201-2002025-04-14
00850005747284Dr. Joel KaplanDr. Joel Kaplan, Inc.0201-2252025-04-14
00850005747291Dr. Joel KaplanDr. Joel Kaplan, Inc.0201-2502025-04-14
00850005747543Dr. Joel KaplanDr. Joel Kaplan, Inc.0302-175-W2025-04-14
00850005747550Dr. Joel KaplanDr. Joel Kaplan, Inc.0302-200-W2025-04-14
00850005747567Dr. Joel KaplanDr. Joel Kaplan, Inc.0302-225-W2025-04-14
00850005747574Dr. Joel KaplanDr. Joel Kaplan, Inc.0302-250-W2025-04-14
00850004857113EDP REACH MEDICAL, INC.EDP-MOS1002024-01-18
05060140201113BathmateDX PRODUCTS LIMITEDHydroXtreme 8 2024-01-01
00850004857106EDP MAXRCREACH MEDICAL, INC.EDP-MAXRC2023-12-28
05060140200963VAXAIDDX PRODUCTS LIMITEDV3 DELUXE2023-10-01
05060140201076BathmateDX PRODUCTS LIMITEDHydromax 8 AB2023-10-01