# K030395: Empi Action Patch Iontophoresis System

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Apr 8, 2003 after 62 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 K912015 (1991). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992708: Iontopatch, Birch Point Medical, Inc. (2000) Summary page 1.
- K983484: Dupel B.L.U.E. Small Iontophoresis Electrode, Empi (1998) Summary page 1.
- K915444: Dupel Iontophoresis Device, Empi (1994) Summary page 1.
- K912015: TBD, Empi Buffered Iontophoresis Electroded MDL. 3, Empi (1991) Summary page 1.

## Most influential descendants
- K132832: Activapatch ET Iontophoresis Patch (2014), 0 descendants of its own
- K091326: Activapatch (2009), 0 descendants of its own
- K070427: Dupel Transport Iontophoresis System (2007), 0 descendants of its own

## Indications for use
The Empi Action Patch Iontophoresis System is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.

Source page: https://510kreport.com/device/K030395
Methodology: https://510kreport.com/methodology