FDA.reportPublic FDA data

Impoaid

Primary DI
00850358007097
Brand
Impoaid
Company
ENCORE, INC.
Model
Ring Kit
Catalog number
44023-001
Device description
Ring Kit
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKYDevice, External Penile Rigidity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKYDevice, External Penile RigidityGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850358007097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850358007097008503580070978503580070970850358007097

GMDN Terms#

Term, Definition table
TermDefinition
Penile rigidity splintA device intended to be worn externally on the penis of a patient affected by erectile dysfunction (ED) (commonly known as impotence) or premature ejaculation to support a flaccid penis during vaginal intercourse. It is typically comprised of a ring/loop worn at the base of the penis that connects, via a stabilizing rod, to another ring/loop worn at the head of the penis; it may also be intended to stimulate a penile erection. It is manufactured with specific characteristics (e.g., length, diameter) for a specified patient (i.e., custom-made) and lubricant may be included. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-475-3091info@revivepremium.com

Regulatory Flags#

DUNS number
614647725
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850358007407Encore44017 RETNP - Carton 1244017 - 122019-02-18
10850358007414Encore44017 UNB - Carton 1244017 - 122019-02-18
10850358007421Encore44017 UNM - Carton 1244017 - 122019-02-18
00850358007400Encore44017 RETNP - 3 kits44017 - 32019-02-18
00850358007417Encore44017 UNB - 3 kits44017 - 32019-02-18
00850358007424Encore44017 UNM - 3 kits44017 - 32019-02-18
00850358007004ImpoaidVTU-144010-0012016-09-01
00850358007011EncoreVTU-144010-1002016-09-01
00850358007028ReviveVTU-1440142016-09-01
00850358007035ReviveVTU-E44016-battery2016-09-01
00850358007042EncoreVA VTU-144017-manual2016-09-01
00850358007059EncoreVA VTU-E44017-battery2016-09-01
00850358007066ReviveVTU-E44017-ret2016-09-01
00850358007073ImpoaidVTU-E44019-0012016-09-01
00850358007080EncoreDeluxe VTU-E44020-0012016-09-01
00850358007103EncoreErect Pro Plus Manual and Battery 40372016-11-12
00850358007110EncoreErect Pro Battery40362016-11-12
00850358007127EncoreErect Pro Manual 40352016-11-12
00850358007134EncoreAMERICAN CONE1100-001USCONE2017-07-25
00850358007141EncoreACRYLIC RING EJECTOR1100-10-0012017-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850076064013Pump Worx Max Boost - White PD Products, LLCLKY2026-05-01
00850076064020Max Boost Pro Flow - Blue/Clear PD Products, LLCLKY2026-05-01
00850076064037Pipedream Beginner's Power Pump - Black PD Products, LLCLKY2026-05-01
00850076064044Pump Worx Max Boost - Black PD Products, LLCLKY2026-05-01
00850076064051Pipedream Beginner's Power Pump - Blue PD Products, LLCLKY2026-05-01
00850076064068Pump Worx Beginner's Vibrating Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064075Max Boost Pro Flow - White/Clear PD Products, LLCLKY2026-05-01
00850076064082Pump Worx Accu-Meter Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064099Pump Worx Rookie of the Year Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064105Pump Worx Max Boost - Blue PD Products, LLCLKY2026-05-01
00850076064112Pump Worx Silicone Power Pump - Blue PD Products, LLCLKY2026-05-01
00850076064129Pump Worx Silicone Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064136Pump Worx Beginner's Power Pump - Purple PD Products, LLCLKY2026-05-01
00850076064143Pump Worx Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
00850076064150Classix Power PumpPD Products, LLCLKY2026-05-01
00850076064167Pump Worx Beginner's Power Pump - Red PD Products, LLCLKY2026-05-01
00850076064174Classix Vibrating Power Pump - ClearPD Products, LLCLKY2026-05-01
00850076064181Pump Worx Beginner's Power Pump - Smoke/Black PD Products, LLCLKY2026-05-01
00850076064198Pump Worx Pistol-Grip Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064204Pump Worx Max-Width Penis Enlarger - Clear/Black PD Products, LLCLKY2026-05-01
00850076064211Pipedream Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
00850005747079Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747260Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747277Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747284Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747291Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747543Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747550Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747567Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14