# K915444: Dupel Iontophoresis Device

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Jul 15, 1994 after 953 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030395: Empi Action Patch Iontophoresis System (2003), 3 descendants of its own
- K043047: Dynatron Ibox Iontophoresis Device (2005), 1 descendant of its own
- K170291: IontoDC (2017), 0 descendants of its own
- K132832: Activapatch ET Iontophoresis Patch (2014), 0 descendants of its own
- K091326: Activapatch (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K915444
Methodology: https://510kreport.com/methodology
