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Viberect Penile Vibratory Stimulation Device

by Reflexonic, LLC 2 variants

510(k) K142304

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 NumberK142304 Date3 Oct 2014ClearedStatusActive

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  • Withdrawn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
KXQ
Device Class
Class II
Regulation
21 CFR Part 884.5960
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Viberect Penile Vibratory Stimulation Device is a vibrator for therapeutic use, genital, designed to stimulate penile afferent nerves via vibratory action. It is classified as a Class II medical device under FDA regulations and is intended to facilitate penile erection through mechanical stimulation, aiding in the management of erectile dysfunction or related conditions. The device operates by delivering controlled vibrations to the genital region, targeting nerve pathways associated with arousal and rigidity.

This device is supplied as a rechargeable, prescription-only system and is intended for single-use per session with multiple recharge cycles. It is not sterile at the point of sale but is intended to be used in a clinical or home setting under medical supervision. The device is MRI-unsafe and must be stored in a dry environment when not in use. Authorized for use in the United States under FDA 510(k) clearance (K142304), it adheres to regulatory standards outlined in 21 CFR 884.5960 for genital vibratory devices.

Other devices from Reflexonic, LLC

Questions

AI-generated answers, 1 Oct 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 Viberect Penile Vibratory Stimulation Device used for?

    The Viberect Penile Vibratory Stimulation Device is designed to facilitate penile erection by mechanically stimulating penile afferent nerves through controlled vibrations. It is intended for therapeutic use in managing erectile dysfunction or related conditions by targeting nerve pathways associated with arousal and rigidity.

  • Is this device intended for single-use or reusable?

    The device is intended for single-use per session, though it is rechargeable and can be used across multiple sessions. Each session requires a new application, but the device itself can be recharged for repeated use.

  • Is the Viberect Penile Vibratory Stimulation Device sterile at the point of sale?

    No, the device is not sterile at the point of sale. It is intended for use in a clinical or home setting under medical supervision, where appropriate sterilization or cleaning protocols should be followed before each use.

  • What storage conditions are required for the Viberect Penile Vibratory Stimulation Device?

    The device must be stored in a dry environment when not in use. Avoid exposing it to moisture or damp conditions, as this could affect its performance or longevity.

  • Can the Viberect Penile Vibratory Stimulation Device be used in an MRI environment?

    No, the device is MRI-unsafe. It should never be used or stored near MRI equipment, as the magnetic fields could potentially damage the device or pose safety risks.