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Pos-T-Vac (IVP-600)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983246

by Pos-T-Vac Inc

Identifiers

510(k) Number
K983246 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 (IVP-600) is an external penile rigidity device designed to provide vacuum therapy for erectile dysfunction. It functions by creating a vacuum around the penis to induce and maintain an erection through mechanical means, aiding blood flow to the corporal bodies.

This device is supplied as a manual vacuum pump system, intended for single-use applications per the manufacturer’s instructions. It is classified as a Class II medical device under FDA regulations (876.5020) and has received 510(k) clearance. The system includes components for creating a vacuum seal and maintaining rigidity, with no indication of MRI compatibility. Storage and handling follow standard aseptic practices for external penile devices, though specific sterility claims are not provided in the data.

Frequently asked questions

What is the primary purpose of the Pos-T-Vac (IVP-600) device, and how does it work?

The Pos-T-Vac (IVP-600) is an external penile rigidity device designed specifically for vacuum therapy to treat erectile dysfunction. It works by creating a vacuum around the penis, which induces and maintains an erection through mechanical means. This vacuum draws blood into the corporal bodies, helping to achieve and sustain rigidity for sexual activity.

Is the Pos-T-Vac (IVP-600) intended for single-use or reusable applications?

The Pos-T-Vac (IVP-600) is explicitly supplied as a manual vacuum pump system intended for single-use applications per the manufacturer’s instructions. This design ensures hygiene and reduces the risk of cross-contamination between uses.

What storage and handling precautions should be taken with the Pos-T-Vac (IVP-600)?

The device follows standard aseptic practices for external penile devices, though no specific sterility claims are provided. It should be stored in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Always handle components with care to maintain their integrity and functionality.

Does the Pos-T-Vac (IVP-600) have any compatibility restrictions, such as MRI use?

The device does not have any explicit indication of MRI compatibility in the provided data. As a precaution, it is recommended to confirm with the manufacturer before using the device in an MRI environment, as metal components or materials could pose risks in such settings.

How was the regulatory pathway for the Pos-T-Vac (IVP-600) determined, and what does that mean for its use?

The Pos-T-Vac (IVP-600) was cleared through the FDA’s 510(k) pathway, specifically under the Traditional review process, and is classified as a Class II medical device (product code: LKY). This means it was determined to be substantially equivalent to a legally marketed device already on the market, ensuring it meets FDA safety and performance standards for external penile rigidity devices.

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. Sources consulted: Timm Medical PosTvac PTV 1000 Manual IVP-600 System ED Pump ... - Amazon, Vacuum Therapy System Product Instructions - Timm Medical, Pos-T-Vac Manual Vacuum ED Pump Kit - IVP-600C

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

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

Sources (1)

  • FDA 510(k) K983246 24 fields · synced Sep 19, 2026