# K060579: Comfort/IO Iontophoresis Electrodes

- Pathway: 510(k) (Abbreviated)
- Applicant: Pepin Mfg., Inc.
- Decided: Apr 20, 2006 after 45 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031053: Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, and I7, Selectivemed Components, Inc. (2003) Summary page 1.
- K914264: Transq 2, Iomed, Inc. (1991) Summary page 1.
- K925800: RH-806, Model Transq, Iomed, Inc. (1994) Summary page 1.
- K040495: Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405, Naimco, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K933620: Iontophoresis Drug Delivery Electrodes. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The Pepin Manufacturing, Inc. iontophoresis electrodes are intended to be used to introduce soluble salts and other dugs into the body.

Source page: https://510kreport.com/device/K060579
Methodology: https://510kreport.com/methodology