# K232020: Iontophoresis  Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Top-Rank Health Care Co., Ltd.
- Decided: Oct 16, 2023 after 101 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: 4 generations back to K912015 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040495: Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405, Naimco, Inc. (2004) Summary page 6.

## Indications for use
Iontophoresis Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.

Source page: https://510kreport.com/device/K232020
Methodology: https://510kreport.com/methodology