# K063465: Champion Iontophoretic Drug Delivery Device

- Pathway: 510(k) (Traditional)
- Applicant: Iomed, Inc.
- Decided: Feb 28, 2007 after 104 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: 5 generations back to K912015 (1991). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974855: Phoresor II, Model PM900, Iomed, Inc. (1998) Summary page 1.
- K982668: Phoresor II,Model PM900, Iomed, Inc. (1999) Summary page 1.
- K932621: RH-801/GS Model Transq (R)1, Iomed, Inc. (1994) Summary page 1.
- K033192: RH-950, Iomed, Inc. (2003) Summary page 1.

## Most influential descendants
- K072946: Hybresis Iontophoresis Drug Delivery System (2007), 0 descendants of its own

## Indications for use
Iontophoretic drug delivery devices 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 HCI 2% and Epinephrine 1:100,000 Topical Solution).

Source page: https://510kreport.com/device/K063465
Methodology: https://510kreport.com/methodology