# K070427: Dupel Transport Iontophoresis System

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: May 14, 2007 after 90 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030395: Empi Action Patch Iontophoresis System, Empi (2003) Summary page 1.
- K915444: Dupel Iontophoresis Device, Empi (1994) Summary page 1.
- K970491: Dupel II Buffered Iontophoresis Electrodes, Empi (1997) Summary page 1.
- K983484: Dupel B.L.U.E. Small Iontophoresis Electrode, Empi (1998) Summary page 1.

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

Source page: https://510kreport.com/device/K070427
Methodology: https://510kreport.com/methodology