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V Quick Patch

by Vq Corp. 510(k)

Active United States

510(k) K993934

Overview

The V Quick Patch is a disposable electrocardiograph electrode and placement device (product code DRX), designed for secure attachment to the skin during cardiac monitoring. It combines adhesive and conductive properties to ensure stable signal acquisition for electrocardiogram (ECG) recordings, facilitating accurate cardiac rhythm assessment.

This device is supplied as a single-use, non-sterile item intended for clinical use in cardiac monitoring settings. It is classified as a Class 2 Cardiovascular device under FDA regulations, cleared via the Traditional 510(k) pathway (K993934). No MRI safety or reusable specifications are noted in the regulatory data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993934 Date15 Aug 2000ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the V Quick Patch primarily used for in clinical settings?

    The V Quick Patch is designed specifically for secure attachment to the skin during cardiac monitoring to ensure stable ECG signal acquisition. Its adhesive and conductive properties help maintain reliable contact, which is essential for accurate cardiac rhythm assessment in clinical environments.

  • Is the V Quick Patch intended for reuse, or is it meant to be used only once?

    The V Quick Patch is explicitly labeled as a single-use device. It is not designed or cleared for reuse, which aligns with its classification as a disposable electrocardiograph electrode and placement system.

  • How is the V Quick Patch supplied, and what should clinicians expect in terms of sterility?

    The V Quick Patch is supplied as a non-sterile item, intended for clinical use in cardiac monitoring. Since it is disposable, sterility is not a requirement for its intended single-use application, but standard infection control practices should still be followed during handling.

  • What regulatory pathway was followed for FDA clearance of the V Quick Patch?

    The V Quick Patch was cleared via the Traditional 510(k) pathway under FDA regulations, specifically under K-number K993934. It was determined to be substantially equivalent to a predicate device and was reviewed by the Cardiovascular (CV) Advisory Committee.