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Reliant Constriction Ring

by Walling Medical Equipment Co.

510(k) K940995

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK940995 Date14 Jun 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LKY
Device Class
Class II
Regulation
21 CFR Part 876.5020
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Reliant Constriction Ring is a medical device classified as an external penile rigidity aid, designed to provide mechanical support for the penis. It functions by applying controlled circumferential pressure to maintain erection through physical constriction, assisting patients with erectile dysfunction or other conditions requiring penile rigidity.

This device is intended for single-use and is supplied sterile, requiring no additional preparation before application. It is regulated under FDA 510(k) clearance (K940995) and falls under product code LKY, categorized within Class II medical devices. Storage instructions and MRI safety are not specified in the available data, but it is intended for use in clinical settings by healthcare professionals.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Reliant Constriction Ring designed to do and who should use it?

    The Reliant Constriction Ring is an external penile rigidity aid that provides mechanical support to maintain an erection through controlled circumferential pressure. It is intended for patients with erectile dysfunction or other conditions requiring penile rigidity, and it is designed for use by healthcare professionals in clinical settings.

  • Is the Reliant Constriction Ring reusable or meant for single-use, and how should it be prepared?

    The Reliant Constriction Ring is explicitly designed for single-use only and is supplied sterile, so no additional preparation is required before application. This ensures patient safety and reduces the risk of contamination.

  • What regulatory pathway does the Reliant Constriction Ring follow, and how is it classified?

    The Reliant Constriction Ring follows the FDA 510(k) clearance pathway and is classified as a Class II medical device under product code LKY. It was determined to be *substantially equivalent* to a legally marketed predicate device, with clearance granted on June 14, 1994 (K940995).

  • Are there different sizes or models available for the Reliant Constriction Ring?

    The provided data does not specify exact sizes or model variations for the Reliant Constriction Ring. However, as an external penile rigidity aid, it is likely designed to accommodate standard penile circumferences. For precise sizing, refer to the manufacturer’s packaging or instructions.