# K040495: Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405

- Pathway: 510(k) (Traditional)
- Applicant: Naimco, Inc.
- Decided: Apr 22, 2004 after 56 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). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932620: RH-806/GS Model Transq (R)2, Iomed, Inc. (1994) Summary page 1.
- K932621: RH-801/GS Model Transq (R)1, Iomed, Inc. (1994) Summary page 1.
- K983484: Dupel B.L.U.E. Small Iontophoresis Electrode, Empi (1998) Summary page 1.
- K882554: Meditrode Kit, Life-Tech Intl., Inc. (1988) Summary page 1.

## Most influential descendants
- K061522: Trivarion Buffered Iontophoresis Electrode System (2006), 2 descendants of its own
- K232020: Iontophoresis  Electrodes (2023), 0 descendants of its own
- K132832: Activapatch ET Iontophoresis Patch (2014), 0 descendants of its own
- K091326: Activapatch (2009), 0 descendants of its own
- K060579: Comfort/IO Iontophoresis Electrodes (2006), 0 descendants of its own

## Indications for use
Naimco, Inc. Iontophoresis Drug Delivery Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.

Source page: https://510kreport.com/device/K040495
Methodology: https://510kreport.com/methodology