Skip to content

SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES - I40

by Selectivemed Components, Inc.

510(k) K031053

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031053 Date20 May 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0799-05 FDA Unclassified (pre-2012) initiated 15 Mar 2005

    The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.

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  • Withdrawn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
EGJ
Models / Variants
I40
Device Class
Class II
Regulation
21 CFR Part 890.5525
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Buffered Iontophoresis Drug Delivery System Electrodes are devices designed to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection. The system consists of an active drug delivery electrode and a passive return electrode, facilitating the local administration of ionic drug solutions into the body for medical purposes.

These electrodes are designed for single-patient, one-time use and are available in multiple sizes and shapes. The device is classified under product code EGJ for Device, Iontophoresis, Other Uses and received FDA 510(k) clearance with K-number K031053 on May 20, 2003.

Other devices from Selectivemed Components, Inc.

Questions

AI-generated answers, 25 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 are Buffered Iontophoresis Drug Delivery System Electrodes used for?

    These electrodes are designed to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection, facilitating local administration of ionic drug solutions for medical purposes.

  • Are these electrodes reusable or single-use?

    The Buffered Iontophoresis Drug Delivery System Electrodes are designed for single-patient, one-time use only and should not be reused between different patients.

  • What sizes and models are available for these electrodes?

    The electrodes are available in multiple sizes and shapes, specifically in Models I20, I30, I40, I50, and I7, to accommodate various treatment needs and anatomical considerations.

  • What is the regulatory status of these electrodes?

    The device is classified under product code EGJ for Device, Iontophoresis, Other Uses and received FDA 510(k) clearance with K-number K031053 on May 20, 2003.