# K060236: MW-1000 Iontophoretic Drug Delivery Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Iomed, Inc.
- Decided: Mar 31, 2006 after 60 days
- Product code: EGJ (Device, Iontophoresis, Other Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K863166 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932621: RH-801/GS Model Transq (R)1, Iomed, Inc. (1994) Summary page 1.
- K042590: Transderm Ionto System, MK 2, Mattioli Engineering Corp. (2004) Summary page 1.

## Indications for use
Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

Source page: https://510kreport.com/device/K060236
Methodology: https://510kreport.com/methodology