# K080580: Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small DDS275, Medium DDM325, Large D

- Pathway: 510(k) (Traditional)
- Applicant: Axelgaard Mfg. Co., Ltd.
- Decided: Jun 18, 2008 after 107 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: 6 generations back to K912015 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052019: North Coast Buffered Iontophoresis Electrode, North Coast Medical, Inc. (2005) Summary page 1.
- K060814: Dynatron Ion Iontophoresis Electrode, Dynatronics Corp. (2006) Summary page 1.

## Indications for use
Iontophoresis is indicated by clinicians for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.

Source page: https://510kreport.com/device/K080580
Methodology: https://510kreport.com/methodology