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Support Ring

by Numedtec, Inc.

510(k) K904485

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 NumberK904485 Date14 Dec 1990ClearedStatusActive

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  • Withdrawn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, 26 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 Support Ring is a device classified as an external penile rigidity device. It is designed to provide support for penile rigidity.

The Support Ring is supplied by Numedtec, Inc. and has FDA 510(k) clearance with product code LKY. It is a Class II device and is not indicated as single-use or reusable. The device is available in various sizes as indicated by the multiple registration numbers associated with it.

Other devices from Numedtec, Inc.

  • Support Pump

    Class II

Questions

AI-generated answers, 26 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 Support Ring used for?

    The Support Ring is designed to provide support for penile rigidity as an external penile rigidity device. It helps maintain rigidity during medical procedures or treatments where penile support is required.

  • Is the Support Ring single-use or reusable?

    The Support Ring is not indicated as single-use or reusable in the device specifications. The manufacturer's instructions should be consulted for proper usage and disposal guidelines.

  • What sizes are available for the Support Ring?

    The Support Ring is available in various sizes as indicated by the multiple registration numbers associated with it. The specific size options should be confirmed with the manufacturer based on the registration numbers provided.

  • What is the regulatory status of the Support Ring?

    The Support Ring has FDA 510(k) clearance with product code LKY and is classified as a Class II device. It received clearance through the traditional pathway with a decision code of SESE (Substantially Equivalent).