# K970491: Dupel II Buffered Iontophoresis Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: May 30, 1997 after 109 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: 1 generation back to K912015 (1991). 1 ancestor in all.
21 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912015: TBD, Empi Buffered Iontophoresis Electroded MDL. 3, Empi (1991) Summary page 1.

## Most influential descendants
- K983484: Dupel B.L.U.E. Small Iontophoresis Electrode (1998), 20 descendants of its own
- K031115: RH-900 (2003), 6 descendants of its own
- K040495: Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405 (2004), 5 descendants of its own
- K031053: Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, and I7 (2003), 4 descendants of its own
- K033192: RH-950 (2003), 3 descendants of its own

## Indications for use
The Dupel® I Buffered Iontophoresis Electrodes are designed for use with the Dupel Iontophoresis System (K903093) which 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/K970491
Methodology: https://510kreport.com/methodology