# K991991: Dupel Iontophoresis System

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Sep 10, 1999 after 88 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970491: Dupel II Buffered Iontophoresis Electrodes, Empi (1997) Summary page 1.
- K912015: TBD, Empi Buffered Iontophoresis Electroded MDL. 3, Empi (1991) Summary page 1.
- K983484: Dupel B.L.U.E. Small Iontophoresis Electrode, Empi (1998) Summary page 1.
- K780310: Dermatron Iontophoresis Device, Motion Control, Inc. (1978) Summary page 1.
- K872040: Phoresor II (TM), Model PM700, Motion Control, Inc. (1987) Summary page 1.
- K934335: Phoresor II Auto, Model PM800 Modification, Iomed, Inc. (1994) Summary page 1.
- K974855: Phoresor II, Model PM900, Iomed, Inc. (1998) Summary page 1.
- K982668: Phoresor II,Model PM900, Iomed, Inc. (1999) Summary page 1.

## Indications for use
Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

Source page: https://510kreport.com/device/K991991
Methodology: https://510kreport.com/methodology