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Pos-T-Vac (rejoyn Vacuum Erection Device)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K981011

by Pos-T-Vac Inc

Identifiers

510(k) Number
K981011 FDA 510(k)
FDA Product Code
LKY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5020 FDA 510(k)
Regulation Number
876.5020 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pos-T-Vac Rejoin Vacuum Erection Device is a mechanical device designed for external penile rigidity, classified under external penile constriction devices. It employs a vacuum mechanism to induce and maintain an erection by drawing blood into the penis, providing temporary rigidity for sexual function.

This device is supplied as a reusable system, intended for home use under medical supervision. It is not sterile upon packaging and must be cleaned and maintained according to manufacturer instructions. The device is regulated under FDA 510(k) clearance and EU MDR, with a product code of LKY and classification as a Class II medical device. Multiple registration numbers and FEI numbers are associated with its distribution.

Frequently asked questions

Is the Pos-T-Vac Rejoin Vacuum Erection Device intended for single-use or reusable applications, and what does this mean for maintenance?

The Pos-T-Vac Rejoin Vacuum Erection Device is designed as a reusable system for home use under medical supervision. Since it is not sterile upon packaging, proper cleaning and maintenance are required per the manufacturer’s instructions to ensure safe and effective use over time. This distinguishes it from single-use devices, which are discarded after one application.

What medical specialties are most relevant to the clinical use of this device, and why?

The Pos-T-Vac Rejoin Vacuum Erection Device is primarily associated with urology and gastroenterology specialties, as indicated by its regulatory filings. While its mechanism directly supports penile rigidity (a urological concern), the device’s classification under external penile constriction devices may also align with broader male sexual health considerations reviewed by gastroenterology advisory committees during regulatory submissions.

How is the device regulated, and what does this imply for its distribution or compliance requirements?

The Pos-T-Vac Rejoin is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), classified as a Class II device with product code LKY. This implies it must meet stringent manufacturing, labeling, and post-market surveillance standards. Multiple FEI (Foreign Establishment Identification) numbers and registration numbers listed reflect its distribution across various global markets, requiring compliance with both U.S. and EU regulatory frameworks.

What does the device’s non-sterile packaging mean for clinical or home use, and how should it be handled?

Since the Pos-T-Vac Rejoin is not sterile upon packaging, it must be cleaned and disinfected between uses to prevent contamination. This is critical for home use, as reusable devices require rigorous maintenance to ensure hygiene and functionality. The manufacturer provides specific cleaning instructions to mitigate infection risks, distinguishing it from sterile, single-use alternatives.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pos-T-Vac Inc
FDA Applicant
Pos-T-Vac, Inc.

Sources (2)

  • FDA 510(k) K981011 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026