# K061522: Trivarion Buffered Iontophoresis Electrode System

- Pathway: 510(k) (Traditional)
- Applicant: Activatek, Inc.
- Decided: Aug 1, 2006 after 60 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). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040495: Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405, Naimco, Inc. (2004) Summary page 1.
- K932620: RH-806/GS Model Transq (R)2, Iomed, Inc. (1994). Our reading of the summary gave K932630, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Iomed TransQ E iontophoresis Electrode”.

## Most influential descendants
- K132832: Activapatch ET Iontophoresis Patch (2014), 0 descendants of its own
- K091326: Activapatch (2009), 0 descendants of its own

## Indications for use
The Trivarion Buffered Iontophoresis Electrode System is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

Source page: https://510kreport.com/device/K061522
Methodology: https://510kreport.com/methodology